
==== Front
Int J Colorectal Dis
Int J Colorectal Dis
International Journal of Colorectal Disease
0179-1958
1432-1262
Springer Berlin Heidelberg Berlin/Heidelberg

4714
10.1007/s00384-024-04714-8
Review
Management of complications in patients with an ileostomy: an umbrella review of systematic reviews for the EndOTrial Consortium
Solitano Virginia 12
Vuyyuru Sudheer Kumar 13
Yuan Yuhong 14
Singh Siddharth 5
Narula Neeraj 6
Ma Christopher 378
Hanzel Jurij 39
Hutton Megan 10
Van Koughnett Julie Ann 11
Rieder Florian 121314
Jairath Vipul vjairath@uwo.ca

1315
1 https://ror.org/02grkyz14 grid.39381.30 0000 0004 1936 8884 Department of Medicine, Division of Gastroenterology, Department of Epidemiology and Biostatistics, Western University, London, ON Canada
2 grid.18887.3e 0000000417581884 Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy
3 grid.518603.9 0000 0004 9413 3241 Alimentiv Inc, London, ON Canada
4 https://ror.org/051gsh239 grid.415847.b 0000 0001 0556 2414 Lawson Health Research Institute, London, ON Canada
5 grid.266100.3 0000 0001 2107 4242 Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, CA USA
6 https://ror.org/02fa3aq29 grid.25073.33 0000 0004 1936 8227 Department of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON Canada
7 https://ror.org/03yjb2x39 grid.22072.35 0000 0004 1936 7697 Division of Gastroenterology & Hepatology, University of Calgary, Calgary, AB Canada
8 https://ror.org/03yjb2x39 grid.22072.35 0000 0004 1936 7697 Department of Community Health Sciences, University of Calgary, Calgary, AB Canada
9 grid.29524.38 0000 0004 0571 7705 Department of Gastroenterology, University Medical Centre Ljubljana, University of Ljubljana, Ljubljana, Slovenia
10 https://ror.org/037tz0e16 grid.412745.1 0000 0000 9132 1600 Nursing Practice Excellence and Innovation, London Health Sciences Centre, London, ON Canada
11 https://ror.org/02grkyz14 grid.39381.30 0000 0004 1936 8884 Division of General Surgery, Department of Surgery, University of Western Ontario, London, ON Canada
12 https://ror.org/03xjacd83 grid.239578.2 0000 0001 0675 4725 Department of Cancer Biology, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH USA
13 https://ror.org/03xjacd83 grid.239578.2 0000 0001 0675 4725 Department of Gastroenterology, Hepatology and Nutrition, Digestive Diseases Institute, Cleveland Clinic Foundation, Cleveland, OH USA
14 grid.239578.2 0000 0001 0675 4725 Program for Global Translational Inflammatory Bowel Diseases, Cleveland Clinic Foundation, Cleveland, OH USA
15 https://ror.org/02grkyz14 grid.39381.30 0000 0004 1936 8884 Department of Epidemiology and Biostatistics, Western University, London, ON Canada
21 9 2024
21 9 2024
2024
39 1 1472 9 2024
© The Author(s) 2024
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.
Background

Standardized clinical care processes for patients with Crohn’s disease (CD) and a permanent ileostomy (PI) are lacking. The EndOTrial consortium aims to address this gap by developing pathways for care.

Methods

In this umbrella review, we searched major databases for relevant systematic reviews (SRs) or scoping reviews (ScR) published until January 5, 2024. Screening, data extraction, and quality appraisal (AMSTAR 2) were performed by two independent reviewers.

Results

Of 1349 screened papers, 22 reviews met our inclusion criteria, including 20 SRs (eight with meta-analysis) and 2 ScRs. None exclusively focused on PI. Furthermore, nine reviews did not mention patients with inflammatory bowel disease (IBD), and only two reviews included patients with high-output ileostomy, highlighting a large evidence gap. The identified reviews covered six categories with nine types of interventions, including ostomy care pathways, peristomal skin care, patient education, clinical management of high-output stoma, management and prevention of postoperative ileus, dietary and nutritional support, nursing and supporting care, telemedicine, and self-management interventions. Most SRs including nursing interventions for stoma care highlighted nurses’ role in a variety of standard and specialized treatments. Notably, none of the reviews exclusively examined disease recurrence, stoma pouching systems or adhesives, behavioral interventions, or mental health in patients living with ileostomy.

Conclusions

Evidence for best practice interventions to treat complications and improve quality of life in patients living with an ileostomy for CD is limited and heterogeneous. These results outline the need for standardized clinical care processes and pathways tailored to the unique needs of this patient population.

Supplementary Information

The online version contains supplementary material available at 10.1007/s00384-024-04714-8.

Keywords

Ostomates
IBD
Umbrella
Stoma
issue-copyright-statement© Springer-Verlag GmbH Germany, part of Springer Nature 2024
==== Body
pmcIntroduction

The creation of an ileostomy, involving the surgical formation of an artificial opening in the abdominal wall to channel ileal effluent, is crucial for managing various gastrointestinal conditions [1]. While ileostomies can be temporary, a permanent ileostomy (PI) may be required in certain scenarios, either because restoring normal bowel function is not possible or based on the patient’s preference. Conditions such as inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), often necessitate this procedure. It is estimated that between 30 and 50% of individuals with CD will undergo at least one surgical operation during their lifetime due to persistent inflammation [2]. These include the development of complications such as strictures, fistulae, abscesses, or dysplasia, which can result in subtotal or proctocolectomy and formation of a PI [3]. Despite progress in controlling intestinal inflammation with several novel therapeutic agents, we recently reported that patients with CD and PI have been universally excluded from all clinical trials evaluating advanced therapies [4]. In another systematic review, we identified clinical trials assessing interventions in patients with an intestinal stoma, with or without CD, listed in clinicaltrials.gov up to May 2022 [5]. We found that out of 253 studies, only 6 exclusively included patients with IBD [5].

Complications following intestinal stoma creation are experienced by around 20% of patients which can encompass immediate, early, or late occurrences. Depending on the underlying pathophysiology of stoma creation, there is a multitude of possible stoma-related complications which can occur including stomal stenosis, parastomal hernia, electrolyte imbalance, dehydration due to high stoma output, bowel obstruction, fistula formation, and peristomal skin irritation [6]. Specific to patients with CD, another concern is the recurrence of CD in the small bowel proximal to the stoma after PI formation. In a meta-analysis of 18 cohort studies examining patients (n = 1438) who underwent subtotal or total colectomy or proctocolectomy with PI, the risk of clinical recurrence after PI was 28.0%, and the risk of surgical recurrence was 16.0% [7]. In a recent meta-analysis, it was found that half of CD patients who underwent ileocolonic resection and anastomosis experienced endoscopic recurrence. Of those with endoscopic recurrence, 33.4% (in randomized controlled trials [RCTs]) to 53.3% (in cohort studies) also experienced clinical recurrence [8]. Furthermore, quality of life, particularly in terms of body image, work and social function, sexuality, and psychological impact after surgery with PI, is of major concern to patients [9].

The EndOTrial consortium, funded by the Helmsley Charitable Trust, is dedicated to addressing the gaps in care provision including development of structured clinical care pathways for patients with CD and PI. To advance this goal, this umbrella review aims to comprehensively consolidate existing knowledge by systematically identifying, critically evaluating, and synthesizing findings from a spectrum of published systematic reviews. Specifically, this review aimed to explore management strategies for mitigating specific complications such as high stoma output, strategies to navigate disease recurrence, optimal approaches to peristomal skin care, considerations surrounding stoma pouching systems and adhesives, efficacy of behavioral interventions, avenues for mental health support, and strategies for dietary management. Through this thorough evaluation, we aimed to provide a better understanding of the existing evidence landscape and pave the way for more tailored and effective care pathways for patients with PI.

Methods

In this umbrella review, our objective was to summarize interventions aimed at prophylaxis or management of complications in patients with ileostomy, including but not limited to high stoma output management, peristomal skin care, stoma pouching systems and adhesive management, optimal approaches to diet and nutrition, behavioral interventions, mental health management, and any other pertinent non-surgical interventions for patients with an ileostomy. For the overview of systematic reviews, we followed the Cochrane collaboration guidelines “Chapter V, Overviews of reviews” [10], the Joanna Briggs Institute manual for umbrella reviews [11], and the recommendations outlined in the Preferred Reporting Items for Overviews of Reviews (PRIOR) [12] (Table S1). We also followed a standardized methodology and reported findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (i.e., PRISMA) [13].

Our methodology involved presenting outcome data exactly as reported in the included systematic reviews, without planning to re-analyze the data differently from the original analyses conducted in these published reviews.

Search strategy

We conducted a search of the following databases from their inception up to January 5, 2024: MEDLINE (Ovid, from 1946), EMBASE (Ovid, from 1974), Cochrane Database of Systematic Reviews (CDSR) (Ovid, from inception), and Epistemonikos (L·OVE platform). The search was restricted to studies published in English. Although conference abstracts were initially included to allow for the retrieval of full publications or comparison with preliminary reports, unpublished conference abstracts were excluded from the final review.

We searched using text terms as well as MeSH or Emtree terms related to ostomy, ileostomy, and stoma, and applied validated filters for systematic reviews and meta-analyses. The detailed search strategy is outlined in Appendix 1. Additionally, we performed a recursive manual search of the references in eligible review articles and meta-analyses to ensure comprehensive identification of all relevant systematic reviews.

Selection criteria

References obtained from the search strategy were entered into the Covidence screening tool (https://www.covidence.org/). Two reviewers [VS, YY] conducted independent and duplicate screenings of the titles and abstracts for all records. Data extraction was also performed independently and in duplicate by these reviewers. Discrepancies were resolved through discussion, and if a consensus was not achieved, a third reviewer [VJ] was consulted to make the final decision.

In our selection process, we established clear criteria for inclusion and exclusion at a protocol a priori. We developed an in-house protocol prior to beginning the review, which is available upon request and not registered on a publicly searchable platform. Firstly, we focused on systematic reviews that included studies involving patients who had undergone an ileostomy, regardless of whether they had IBD or not, and irrespective of the primary study design. Additionally, we included systematic reviews that described interventions for various aspects of ileostomy management, such as ostomy care pathways, peristomal skin care, patient education, management of high-output stoma, stoma pouching systems and adhesives, behavioral interventions, mental health, diet and nutrition, prevention of disease recurrence, and other relevant non-surgical interventions to prevent or management post-PI complications.

We applied several exclusion criteria to refine our selection. We excluded systematic reviews that solely included other types of ostomy, such as cystostomy, colostomy, gastrostomy, jejunostomy, or urostomy. We also omitted narrative reviews from consideration. Furthermore, systematic reviews that did not specifically involve patients with an ileostomy or those that solely focused on temporary ileostomies or a mix of colostomy and temporary ileostomy, were excluded. We excluded systematic reviews that only included patients with cancer and did not include any IBD patients. We also excluded reviews concentrating on diversion proctocolitis in IBD patients following fecal diversion or those addressing surgical management of ostomy complications. Additionally, evidence-based guidelines identified during our search, even if based on systematic reviews, were not included. During the screening phase, we omitted systematic reviews that did not primarily focus on interventions designed for ileostomy management.

Data extraction

A study-specific extraction form was used to collect data by two independent reviewers. Data was extracted using a standardized form, which was piloted before use. Data were synthesized narratively using the following data that were extracted: year of publication, searched date, searched databases, number of studies, study design category of included studies, study arms, study intervention, type of ileostomy, included population, outcomes, and key results.

Outcomes

Outcomes were documented and analyzed independently for each intervention. Some outcomes were reported involving different interventions. We pre-specified our outcomes of interest a priori in the protocol and assessed various outcome measures across different domains related to the clinical management of patients with an ileostomy. These outcomes were organized according to specific interventions and included the following:Clinical management of high-output stoma: evaluation criteria comprised reduction in stoma volume output (e.g., as a reduction in intestinal output of > 25%) compared to pretreatment conditions, decrease in intestinal output in milliliter [14], dehydration, electrolyte imbalance, and renal dysfunction.

Peristomal skin care: assessment focused on skin irritation, as defined, and reported by primary studies.

Dietary management: evaluation included dietary restrictions, supplementation, and adjustments tailored to manage high-output stoma and maintain nutritional balance in ostomates.

Procedure-specific complications: this category encompassed immediate, early, and late procedure-specific complications. Immediate category addresses complications that arise immediately following the surgical procedure, ischemia or necrosis, gastrointestinal hemorrhage, infection or intra-abdominal abscess, hematoma or seroma, and anastomotic dehiscence. Early group includes complications that manifest shortly after the surgery, typically within the first few weeks to months, such issues related to wound healing, incisional hernia, postoperative bowel obstruction, postoperative ileus, and postoperative leaks. Late complications encompass parastomal hernia occurrence, stricture or stenosis, parastomal varices, stoma retraction or prolapse, parastomal fistula formation.

Quality of life (QoL): assessment tools included the Stoma Quality of Life scale, EQ-5D-3L, Short Quality of Life in Inflammatory Bowel Disease questionnaire, Cleveland Global Quality of Life instrument, and Fecal Incontinence Quality of Life scale.

Mental health: evaluated aspects encompassed intimacy, anxiety or depression, self-esteem, self-efficacy, and self-disgust, measured using validated assessment tools.

Readmission due to complications or IBD recurrence.

Quality assessment

The quality of systematic reviews and meta-analyses was independently assessed by two reviewers (VS and YY) using the AMSTAR 2 tool, which evaluates the methodology of systematic reviews and meta-analyses [15]. This tool includes 16 criteria that assess aspects such as search comprehensiveness, reporting standards, and analytical rigor, providing an overall confidence rating of high, moderate, low, or critically low [15]. For scoping reviews, where no validated quality assessment tool exists, we evaluated reporting quality based on the PRISMA Extension for Scoping Reviews (PRISMA-ScR). Any disagreements regarding the risk of bias were resolved through discussion among the reviewers. If agreement could not be reached, a third reviewer (VJ) was consulted to make a final decision. Risk of bias was not evaluated for scoping reviews [16].

Results

A total of 1349 references were initially identified, and after removing duplicates, 1008 references underwent screening. Subsequently, 92 full-text papers were reviewed (Fig. 1). Among these, twenty-two reviews met our inclusion criteria. None of the systematic reviews specifically focused on patients with PI. Among all reviews and guidelines, there were 20 systematic reviews (including only eight with meta-analyses) and two scoping reviews, all of which are summarized in Table 1. It is noteworthy that nine of these reviews did not specify whether they included patients with IBD, and only two reviews included patients with high-output ileostomy [17, 18]. Among the included papers, a total of nine interventions in six categories were appraised and summarized across six key areas of stoma care as follows (Table 1):Fig. 1 Summary of the evidence search and selection process (flowchart)

Table 1 Characteristics of 22 included systematic reviews of interventions

Author/year	Type of SR/ScR/MA/	Type of ileostomy/ostomy/intestinal stoma	Included IBD patients	Interventions/comparisons	Outcomes/key results	
Preventive care and patient education (n = 7)	
Ostomy care pathways (n = 1)	
Nizum 2022 [19]	SR	Ostomies (included colostomy, ileostomy, urostomy)	Not mentioned	Ostomy care pathways included preoperative education and counseling, postoperative education and discharge planning, and outpatient home visits and telephone follow-ups	Ostomy care pathways may contribute to patient satisfaction and decrease both hospital LOS and hospital readmission rates	
Peristomal skin care (n = 2)	
Afifi 2018 [20]	SR	Ileostomy (78%) or colostomy or other stoma	Most patients had IBD (81%: CD 50%, UC 31%)	Peristomal pyoderma gangrenosum management	• Systemic steroids are first-line therapy

• Infliximab and adalimumab provide concomitant control of active IBD

• Combination local and systemic therapy is commonly used

• Wound dressings, vehicle selection, and appropriate ostomy devices to minimize leakage, irritation, and pressure-induced ischemia can improve healing

	
Tam 2014 [21]	SR + MA	Colostomy or ileostomy (not separate data for ileostomy or PI)	Only in introduction mentioned IBD as one of the indications for stomas	Standard peristomal skin care to adjunctive techniques or barriers (glycogel dressings, gelatin- and pectin-based skin barriers, glycerin hydrogel wound dressing, Acacia senegal fiber pockets, hydrocolloid powder crusting, and German chamomile)	• Incidence of skin problems (RR = 0.67; 0.31–1.41)

• Length of pouch wear time (MD = 0.48; 0.03–7.97)

	
Patient Education (n = 4)	
Liu 2023 [25]	SR	Ostomies (colostomy, ileostomy, enterostomy)	Not mentioned	Stoma self-management education	• Two or three health education sessions over seven days are sufficient to empower in-hospital patients to undertake stoma self-care

• The transtheoretical model, chronic care model or the use telehealth can help maintain and reinforce self-care behaviors after discharge

	
Faury 2017 [22]	SR	Ileostomy or colostomy, temporary or permanent	All studies included adults with CRC and intestinal stoma. Four studies also included IBD patients	Patient education applying quantitative methods	• Patient education improved some psychosocial and self-management skills

• Contrasting findings were reported for specific-disease QoL, emotional distress, LOS, stoma complications and readmission rate

	
Phatak 2014 [24]	SR	Ostomy, ileostomy and colostomy, included references for temporary or permanent	Two studies included IBD patients	Educational interventions for new ostomates designed to decrease stoma-related complications	Education is a key component of patient care, evidence to support an improvement in clinical outcomes is lacking	
Danielsen 2013 [23]	SR	Ostomy (included ileostomy, colostomy) temporary or permanent stoma	Not mentioned	Structured educational programme related to living with a stoma	• Increase in HRQOL, in proficiency in management of the stoma

• Significant reduction in cost in the intervention group

• Higher effectiveness scores in the intervention group compared with the control group

• Significant rise in stoma-related knowledge and an increase in psychosocial adjustment

	
Clinical management (n = 4)	
Clinical management of high-output stoma (n = 2):	
Lederhuber 2023 [18]	SR + MA	Of 768 patients: 248 ileostomies, 132 jejunostomies and 328 unspecified small bowel stomas	28 of 32 studies included some patients with IBD	18 interventions: omeprazole loperamide, somatostatin analogues, oral rehydration salt, marshmallows, glucodrate, codeine, soy polysaccharide, clonidine, cholylsarcosine, H2RAs (cimetidine, ranitidine), high-sodium rehydration solution, budesonide, GLP-1/2 receptor agonists (teduglutide, liraglutide, glepaglutide), bowel content or chyme reinfusion, omeprazole, antisecretory powder, thickening powder, intake restriction	• Absolute stoma output:

no difference in stoma output between controls vs: somatostatin analogues (g − 1.72, 95% CI − 4.09 to 0.65) (n = 5); loperamide (g—0.34, − 0.69 to 0.01) (n = 5); omeprazole (g—0.31, 95% CI—2.46 to 1.84) (n = 2)

• Stoma output compared to baseline: reduction reported in 17 trials

	
Makowsky 2019 [17]	Case report and SR	High-output ileostomy	Two case reports included patients with CD	Subcutaneous magnesium sulfate to correct high-output ileostomy-induced hypomagnesemia	Home-based intermittent administration of subcutaneous magnesium may be a helpful and safe to temporarily prevent and treat select patients with recurrent symptomatic hypomagnesemia	
Management and prevention of postoperative ileus (n = 2)	
Li 2013 [26]	SR + MA	Varied abdominal surgeries: only one RCT included ileostomy	Not mentioned	Chewing gum vs groups without using chewing gum to reduce postoperative ileus	Overall time (in days) to pass flatus (WMD =  − 0.31; − 0.43 to − 0.19); time to bowel movement (WMD =  − 0.51; − 0.73 to − 0.29), LOS (WMD =  − 0.72; − 1.02 to − 0.43)	
Hocevar 2010 [27]	SR	Postoperative ileus in patients undergoing ostomy surgery. Ostomies included colectomy or ileostomy	Not mentioned	Chewing gum vs standard postoperative care	Chewing gum was consistently found to reduce time to passage of flatus and stool, but mixed results when compared to standard postoperative care	
Dietary and nutritional support (n = 2)	
Dietary management (n = 2)	
Mitchell 2021 [28]	ScR	Ileostomy (not separate data for permanent or temporary)	Patients with ileostomy due to CD or UC were most frequently studied	Dietary management of ileostomies: nutrient modifications, individual foods/drinks; eating-related behaviors	• Most common nutrients reported in association: fiber, fat, and alcohol

• Most commonly reported outcomes: stoma output volume and consistency

• Flatulence and odor in observational studies

	
Herbert 2019 [29]	Cochrane review + MA	Included all lower GI surgery, including ileostomy	One RCT included 21 IBD patients	Early enteral nutrition within 24 h of lower GI surgery vs later commencement	• LOS: MD = 1.95 (95% CI, − 2.99 to − 0.91) days shorter in the early feeding group

• Incidence of postoperative complications: no difference

• Mortality, vomiting, nausea: no difference

• QoL scales: no difference

	
Nursing and supporting care (n = 6)	
Nursing and supporting care (n = 6)	
Panattoni 2023 [30]	ScR	Any ostomy (tracheostomy, gastrostomy, jejunostomy, ileostomy, colostomy and urostomy)	Only in introduction mentioned IBD as one of the major indications	Nursing core competence and skills in stoma care of any type of ostomy throughout the patient’s ostomy surgery candidate care pathway from preoperative to follow-up	Caring for an ostomy patient requires advanced skills and a trusting relationship	
Guo 2023 [31]	SR + MA	Ostomies (ileostomy, colostomy, ileal conduit)	One included study included IBD patients	Experimental nursing interventions included teleconsultation, home-based nursing intervention, multimedia learning education program, evidence-based continuing care bundle, home care mobile app, self-efficacy intervention, nursing intervention combined with early nutritional support, enterostomal nurse telephone follow-up, etc	Experimental nursing intervention showed higher positive effects on the QoL when compared to routine nursing intervention for stoma patients	
Heydari 2023 [33]	SR	Ostomy (colostomy, ileostomy, and urostomy)	Only in the introduction mentioned IBD as one of the major indications	Nursing interventions on the QoL of patients with an ostomy	A regular care plan can be used with the participation of families and patients from pre-operational to discharge along with nurses’ follow-ups and home care to promote the QoL	
Recalla 2013 [32]	SR	Ostomy (colostomies, ileostomies, and urostomies). Also searched: enterostomy, cecostomy, continent ileostomy, duodenostomy, jejunostomy, urinary diversion, fecal diversion, ostomy care, peristomal skin care, etc	Only quoted a UC study for Q1	Ostomy Care and Management	Limited empirical research supporting nurses’ roles in assessing and managing stomas and peristomal skin	
Pittman 2009 [34]	SR	Ostomy: colostomy or ileostomy, temporary or permanent	Not mentioned	Nursing interventions on HRQOL in patients with an intestinal ostomy	• Support for the effectiveness of specific nursing interventions in enhancing HRQOL among individuals with intestinal ostomies

• Validation and reliability of three specific HRQOL measurement instruments—SQOLS, COHQOL-O, and Stoma-QOL—for research purposes

	
Jin 2022 [35]	SR + MA	Ileostomy or colostomy or others	Not mentioned	Continuing care as an extension of post-discharge care vs routine care	Continuing care improved health outcomes and care satisfaction, including significant effects on improving stoma self-efficacy, QoL and reducing stoma complications	
Technological interventions (n = 2)	
Telemedicine (n = 2)	
Zhang 2024 [36]	SR + MA	Enterostomy (ostomy, colostomy, ileostomy)	Not mentioned	Telemedicine vs to the usual group	Telemedicine group significantly reduced the overall occurrence of stoma-related complications, with a decrease in stoma complications and peristomal complications	
Moulaei 2023 [37]	SR	Fecal ostomy (colostomy or ileostomy)	Not mentioned	Technology-based interventions: [1] sensor-based wearable technologies, which were mostly used to assess the fecal output and fullness of ostomy pouching system, and [2] computer-based, tablet based, and smartphones platforms	• Sensor-based smart wearable technology enhances self-care management, benefiting both physical and emotional health

• By utilizing such technology, patients can effectively manage ostomies, reducing complications

• Health information technologies offering educational and self-care services decrease hospital stays and readmission rates

	
Self-management interventions (n = 1)	
Self-management interventions on QoL, self-management skills, and self-efficacy (n = 1)	
Goodman 2022 (38)	SR + MA	Bowel stoma after colostomy/ileostomy (not separate data for ileostomy or PI)	One RCT included 18 IBD patients and others	Self-management programme/interventions	• QoL: SIBDQ mentioned but not reported in review

• Self-management reported using different measurements

• Self-efficacy scores (MD = 11.57; 9.13–14.00)

	
CD Crohn’s disease, CI confidence interval, COHQOL-O City of Hope Quality of Life Ostomy, CRC colorectal cancer, GI gastrointestinal, GLP glucagon-like peptide, H2RAs H2 receptor antagonists, HRQOL health-related quality of life, IBD inflammatory bowel disease, LOS length of stay, MA meta-analysis, MD mean difference, PEG percutaneous endoscopic gastrostomy, PI permanent ileostomy, QoL quality of life, RR risk ratio, SIBDQ Short Inflammatory Bowel Disease Questionnaire, SQOLS Stoma Quality of Life Scale, SR Systematic Review, ScR scoping review, Stoma-QOL Stoma-Quality of Life, TBS telephone-based support, UC ulcerative colitis, WMD weighted mean difference, WOC wound, ostomy, and continence, WOCN Wound, Ostomy, and Continence Nurses Society

Preventive care and patient education

Ostomy care pathways.

Only one systematic review summarized ostomy care pathways, encompassing 11 studies [19]. This systematic review found that ostomy care pathways involving multidisciplinary teams and specialized stoma nurses significantly enhanced patient satisfaction while simultaneously reducing both hospital length of stay and readmission rates. These pathways involved preoperative education and counseling, postoperative education, discharge planning, and outpatient home visits and telephone follow-ups. Preoperative education implied informing patients about ostomy surgery, daily living adjustments, and self-care. Postoperative education included teaching stoma self-management and reviewing potential complications.

Peristomal skin care

This outcome was evaluated in two systematic reviews (one with meta-analysis) [20, 21]. The systematic review focused on 79 studies on peristomal pyoderma gangrenosum management in patients (81% with IBD) with ileostomy or colostomy in order to identify effective treatments available for its management [20]. For mild cases without active systemic disease, topical agents (corticosteroids and calcineurin inhibitors) suffice for management. However, more severe cases may necessitate systemic medication or surgical intervention. These treatments included systemic steroids as first-line therapy, in addition to infliximab and adalimumab for active IBD control.

The other systematic review conducted a meta-analysis to calculate a pooled effect size for the skin irritation/reaction and the length of pouch wear time outcomes [21]. Based on a meta-analysis of four randomized controlled trials (RCTs) (6 in total, including 2 studies enrolling patients with a percutaneous endoscopic gastrostomy [PEG]) adjunctive techniques or barrier products (e.g., glycogel dressings, gelatin- and pectin-based skin barriers, glycerin hydrogel wound dressing, Acacia senegal fiber pockets, hydrocolloid powder crusting, and German chamomile) did not reduce the skin irritation incidence (relative risk (RR) = 0.67; 95% CI, 0.31–1.41) or pouch wear time (mean difference [MD] = 0.48; 95% CI, 0.03–7.97) when compared to standard peristomal skin care techniques (water cleansing and direct application of ostomy pouching systems). A subgroup analysis confirmed that there were no significant differences between the experimental and control groups in both the PEG subgroup (RR = 0.56, 95% CI, 0.20–1.59) and the colostomy/ileostomy subgroup.

Patient education

This outcome was evaluated in four systematic reviews [22–25]. A systematic review on 15 studies appraised education interventions delivered pre- and postoperatively by different providers (e.g., multidisciplinary team, nurses, surgeons, trained expert patients) in individuals with colorectal cancer and stoma, and reported mixed effects on QoL, highlighting positive impacts on psychosocial and self-management skills [22]. On the contrary, another systematic review found that patient education either before or after stoma creation patients improved QoL, stoma management, and psychosocial adjustment while reducing hospital stay and costs [23]. Phatak et al. reviewed 7 studies about educational interventions involving specialized nurses, and evaluated outcomes such as length of stay, complications, and readmissions. Findings were heterogeneous, with some studies reporting reduced length of stay and complications, others no difference [24]. Finally, a recent systematic review of 9 studies summarized different ostomy self-management education approaches [25]. These approaches including a transtheoretical model (including five stages of behavior change: pre-contemplation, contemplation, preparation, action, and maintenance), chronic care model, tele-health and multimedia-based programmes, helped improve patients’ self-care ability and helped maintain and reinforce self-care behaviors following discharge.

2. Clinical management

Clinical management of high-output stoma

This outcome was assessed in two systematic reviews (one with included meta-analysis) [17, 18]. A systematic review with meta-analysis included 32 studies (15 RCTs, 13 non-randomised prospective trials, and 4 retrospective cohort studies) involving 768 patients, and assessing 18 different interventions. The meta-analysis did not find significant differences in stoma output between commonly evaluated agents such as loperamide (Hedges’ g − 0.34, 95% confidence interval [CI] − 0.69 to 0.01), somatostatin analogues (g − 1.72, 95% CI − 4.09 to 0.65), omeprazole (g − 0.31, 95% CI − 2.46 to 1.84), and controls [18]. Another systematic review of 14 reports (11 case reports, 2 retrospective chart reviews, 1 retrospective case series) aimed to describe the administration of magnesium (sulfate) given via subcutaneous infusion for the treatment of high-output ileostomy-induced hypomagnesemia. Subcutaneous magnesium might be beneficial and safe approach for treating recurrent symptomatic hypomagnesemia in selected patients. Since magnesium dosage regimens reported in included studies varied, authors referred to clinical practice guidelines which suggests 4 mmol magnesium sulfate may be added to 500–1000 mL of saline and be given subcutaneously 1–3 times a week if needed [17], and concluded that administering subcutaneous magnesium sulfate intermittently along with hydration fluids at home could be a beneficial and safe, yet often overlooked, approach to sustain serum magnesium levels in patients with high-output ostomies and frequent hypomagnesemia [17, 18].

Management and prevention of postoperative ileus

Two systematic reviews focused on this outcome [26, 27]. One systematic review assessing the use of chewing gum in patients undergoing abdominal surgery performed a meta-analysis on 17 RCTs, of which one had ileostomy as indication of surgery. Gum chewing after abdominal surgery was found to significantly reduce the time to resolution of postoperative ileus (MD =  − 0.51; 95% CI, − 0.73 to − 0.29) and length of hospital stay (MD =  − 0.72; 95% CI, − 1.02 to − 0.43; P < 0.05) compared to groups without using chewing gums [26]. Another systematic review of 7 studies concluded that compared to standard postoperative care, chewing gum reduce time to passage of flatus and stool, but mixed results when compared to standard postoperative care [27].

3. Dietary and nutritional support

Dietary management

This outcome was appraised in two studies, consisting of one scoping review [28], and one systematic review with concomitant meta-analysis [29]. On a meta-analysis of 17 RCTs with 1437 participants undergoing lower gastrointestinal surgery, including also ileostomy, early enteral nutrition within 24 h of lower GI surgery led to a shorter length of hospital stay without increasing the risk of postoperative complications, mortality, or adverse events such as vomiting and nausea [29]. A scoping review of 31 studies highlighted a spectrum of postoperative dietary strategies with inconsistent effects, notably focusing on fiber, fat intake, and alcohol, with low-fiber and low-fat diets generally beneficial in reducing volume of stoma output and alcohol consumption deemed responsible for increasing output [28]. Among all studies, output volume and consistency were frequently reported outcomes, along with issues like flatulence and odor.

4. Nursing and post-discharge supporting care

Nursing and post-discharge supporting care

The impact and importance of nursing care was addressed in five studies (one scoping review, four systematic reviews one of which included a meta-analysis) [30–34]. The scoping review highlighted the importance of strengthening the role of stoma care nurse specialists in delivering therapeutic education, evaluating, preventing, and managing early and late stoma complications, and selecting the most appropriate pouching system, particularly in the Italian context [30]. Another systematic review, which included 10 studies and performed a meta-analysis, demonstrated that experimental nursing interventions (holistic hospital-family care, evidence-based bundles, home-based interventions using health belief models, teleconsultation for self-efficacy, nurse-led multicomponent approaches, nutritional support integration, self-efficacy interventions, mobile app care, and multimedia education) showed higher positive effects on the QoL compared to routine nursing intervention for stoma patients (MD between experimental nursing intervention group and routine nursing intervention group = 7.79; 95% CI, 4.85–10.74) [31]. A systematic review conducted by a task force from the Registered Nurses’ Association of Ontario identified a lack of empirical evidence on the roles of nurses in assessing and managing stomas and peristomal skin [32]. The review highlighted a notable gap in understanding the qualifications and skills required for effective stoma care, as none of the studies compared the effectiveness of different types of providers, such as general nurses versus specialized nurses or other healthcare professionals.

In a separate systematic review, it was suggested that a structured care plan involving family and patient participation from the preoperative stage through to discharge, along with ongoing follow-up and home care by nurses, could enhance the QoL for patients with an ostomy [33]. Another systematic review assessed the validity and reliability of nursing interventions (including physical care, ostomy teaching while in hospital and home-visits following discharge) on QoL in patients with an intestinal ostomy, concluding that nursing interventions can mitigate the negative impact of stoma on QoL. Based on the analysis of three studies, authors concluded the Stoma Quality of Life Scale, City of Hope Quality of Life Ostomy, and Stoma-quality of life are valid and reliable instruments for measuring QoL for research purposes [34].

Regarding post-discharge care, a systematic review and meta-analysis [35] of nine studies concluded that continuing care (including telephone follow-up calls, home-visits) provided by nurses improved health outcomes and care satisfaction, including significant effects on improving stoma self-efficacy (MD = 6.46; 95% CI, 3.81–9.11), QoL (MD = 7.48; 95% CI, 5.13–9.82), and reducing stoma complications (RR = 0.71; 95% CI, 0.58–0.87).

5. Technological interventions

Telemedicine

This outcome was assessed in two systematic reviews [36, 37]. A systematic review with meta-analysis included 22 studies to investigate telemedicine as an intervention to prevent stoma-related complications in adults with enterostomy [36]. The results indicated that compared to the usual care group, the telemedicine group exhibited a significant reduction in the overall occurrence of stoma-related complications (Odds ratio [OR] = 0.22; 95% CI = 0.15–0.32). Specifically, there was a notable decrease in both stoma complications (OR = 0.27; 95% CI = 0.15–0.47) and peristomal complications in the telemedicine group (OR = 0.25; 95% CI = 0.19–0.34). Another study focused on the effects of technology-based interventions (included sensor-based wearable technologies, which were mostly used to assess the fecal output and fullness of ostomy pouching system, and computer-based, tablet based, and smartphones platforms) [37]. Based on evidence from 10 studies, sensor-based smart wearable technology has the potential to improve self-care management and can improve the physical and emotional health. Using sensor-based smart wearables and information technology, patients can better manage and control the ostomy and reduce its complications. Providing educational and self-care services through health information technologies can reduce the length of hospital stay and the rate of hospital readmissions.

6. Patient-centered approaches

Self-management interventions on QoL, self-management skills, and self-efficacy

This outcome was evaluated in a systematic review with a meta-analysis [38]. On a meta-analysis of 16 studies, self-management interventions for individuals with a stoma found positive effects on self-efficacy and self-reported self-management skills [38]. However, outcome measures were not pooled because some were subjective QoL scores and others were objective measures of self-management (e.g., time to stoma proficiency and observation of stoma ability). Across all studies including different credible educational sources (e.g., nurse, doctor, therapist), direct involvement of a nurse in teaching stoma care management preoperatively during psychoeducational sessions was associated with improved self-efficacy and self-management skills and contact postoperatively and self-monitoring were associated with higher QoL.

None of the reviews focused specifically on disease recurrence, stoma pouching system and adhesives, behavioral interventions, or mental health in patients living with ileostomy.

Quality assessment

Of the 20 SRs with or without meta-analysis, the AMSTAR 2 rating was determined to have quality (translated as overall confidence of results) as high in seven systematic reviews, moderate in one, low in two, and very low in ten systematic reviews, respectively. The most common critical flaws were lack of satisfactory technique for assessing the risk of bias, lack of adequate explanation for the selection of study designs, lack of discussing heterogeneity, and lack of reporting on the sources of funding for the studies included (Table S2).

For the two scoping reviews that related to diet management [28] and nursing specialists in the care pathway [30], we used the PRISMA-ScR checklist to assess their reporting quality (Table S3) [16]. Both scoping reviews followed the checklist, both did not conduct a critical appraisal of the included sources of evidence, and one of them did not have a registered protocol [30]. Overall, both scoping reviews were well-conducted.

Discussion

This umbrella review aimed to consolidate the current understanding of management of patients living with ileostomies, particularly those with PI resulting from CD. The results reveal significant gaps in the literature, emphasizing the critical necessity for standardized clinical care approaches tailored specifically to this patient population.

A key finding from this review is the sparse and heterogeneous evidence concerning interventions for management of patients living with PI. Despite the considerable impact of complications related to CD necessitating a PI, our analysis reveals a noticeable lack of evidence specifically addressing this subgroup. Nevertheless, the review identified several intervention areas covered by existing literature that warrant additional research including clinical management of high-output stomas, peristomal skin care, dietary management, patient education, self-management interventions, and eventually ostomy care pathways.

Regarding clinical management, a high-output stoma is a frequent condition after stoma formation [39]. While there is no universal consensus, a small bowel stoma output surpassing 1500 to 2000 mL is often categorized as “high output,” potentially resulting in dehydration, malnutrition, electrolyte imbalances, and skin irritation around the stoma [40]. We did not find high-quality evidence supporting the superiority of any widely used pharmacological agents for high-output stomas management. The intermittent administration of subcutaneous magnesium sulfate alongside hydration fluid at home presents as a potentially beneficial and safe yet overlooked intervention for maintaining serum magnesium levels in patients with high-output ostomies and recurrent hypomagnesemia, but agreement about doses and regimens is lacking. This approach, if applied to appropriate patients, could potentially mitigate the need for frequent emergency department visits, hospital admissions, and infusion clinic visits for intravenous magnesium supplementation.

Among stoma-related issues, peristomal skin complications are both common and significantly impactful, affecting patient well-being and presenting substantial health economic concerns [41, 42]. Timely diagnosis and treatment are essential to prevent long-term, debilitating, and costly complications [43]. A meta-analysis examining various adjunctive techniques and barrier products—intended to reduce skin irritation and prolong pouch wear time—found no significant advantage over standard peristomal care methods such as water cleansing and the application of ostomy pouching systems [21]. Despite testing different products like glycogel dressings and hydrocolloid powder crusting, their effects on skin irritation and pouch wear time were comparable to conventional care approaches. For mild cases of peristomal pyoderma gangrenosum without active systemic disease, topical treatments such as corticosteroids and calcineurin inhibitors are usually sufficient, while more severe cases may require systemic medication or surgical intervention.

In terms of dietary management, the evidence highlights the significant role of dietary interventions in improving postoperative outcomes for patients with stomas. Early enteral nutrition within 24 h following lower gastrointestinal surgery, as shown in a meta-analysis of 17 randomized controlled trials, offers clear benefits, including reduced hospital stay length without increasing the risk of postoperative complications or adverse events [29]. Additionally, a scoping review underlines the importance of dietary strategies, noting that low-fiber and low-fat diets effectively reduce stoma output, while alcohol consumption is associated with increased output [28]. However, individual responses to dietary changes can vary, with most recommendations stemming from expert opinions rather than robust research [44, 45]. For instance, caffeinated beverages might negatively impact stoma output, whereas white starchy carbohydrates could be beneficial [28]. Future research should focus on developing tailored dietary protocols that address individual patient needs and optimize nutritional support to enhance long-term outcomes and QoL.

All included studies highlighted the vital role of stoma nurses, also known as Nurse Specialized in Wound, Ostomy and Continence (NSWOC) in Canada or Wound, Ostomy Continence Nurse (WOCN) in the USA or even gastrointestinal surgery nurses, in providing care and support to individuals who have undergone ostomy surgery. Nursing interventions for stoma care encompass a variety of standard and specialized treatments aimed at empowering patients with comprehensive knowledge and skills for effective stoma management and improving their QoL. In the context of patient education and self-management interventions, nurses offer invaluable support by providing comprehensive education, emotional assistance, and practical guidance, enabling patients to effectively manage their condition and navigate the unique challenges associated with stoma care. Dedicated care by ostomy nursing specialists includes pre-surgery stoma site selection, counseling, postoperative training, assistance with ostomy care and pouch selection, and regular follow-ups. Training focuses on self-care, equipment management, proper use of ostomy pouching systems, skin care, social well-being, anxiety management, and lifestyle adjustments. Their role should be clearly integrated within a multidisciplinary approach involving surgeons, physicians, dieticians, and psychologists. For example, their involvement in the preoperative phase is essential for a thorough understanding of the ostomy system and potential peristomal skin issues post-surgery. While ostomy nurses typically lead, dermatologists may step in for complex or persistent peristomal skin conditions. This underlines the importance of adequately trained professionals in managing peristomal skin conditions and establishing standardized protocols and specific care pathways to reduce their occurrence. Stoma nurses are also the healthcare practitioners most frequently providing dietary advice to people with an ileostomy, followed by dietitians and colorectal surgeons [28].

Ostomy care pathways are also needed as structured frameworks implemented at the organizational level to standardize care for individuals anticipating or living with an ostomy. These pathways encompass a range of standardized work processes, care protocols, and interdisciplinary approaches designed to optimize patient outcomes. They typically involve coordinated treatment, management, and follow-up strategies delivered by members of an interprofessional healthcare team. Studies suggest that education may positively affect patient-centered outcomes such as reducing anxiety and improving QoL. For instance, preoperative education has been associated with lower postsurgical anxiety scores and readmissions for dehydration [46]. Regarding post-discharge follow-up, individuals with ostomies favor direct access to a designated ostomy-trained nurse or healthcare provider over seeking emergent health visits for managing complications after leaving the hospital. From a health equity standpoint, establishing standardized ostomy care pathways guarantees uniform care provision across diverse populations. We acknowledge that the type of healthcare system could potentially influence access to education and support services for patients living with stoma. Future research could benefit from a focused analysis on how different healthcare systems and insurance models impact the effectiveness of patient education interventions.

However, it is important to note that none of the reviews exclusively examined stoma pouching systems and adhesives, behavioral interventions, or mental health support for ileostomy patients. According to a recent study, nearly half of patients undergoing stoma surgery experience depressive symptoms, surpassing rates observed in both the general population and specific cohorts such as those with IBD and colorectal cancer [47]. Optimizing stoma patient outcomes and promoting postoperative psychosocial adjustment are vital and may be facilitated by heightened psychological evaluation and targeted care interventions during the perioperative period. These gaps in the literature highlight areas where further research is needed to better understand and address the comprehensive care needs of patients with ileostomies, particularly those with PI.

The main limitation of this umbrella review is the lack of high-quality studies. Many of the studies evaluated using the AMSTAR2 scale exhibited critical flaws, raising significant concerns regarding bias. With the limitations in mind, it is important to note that the interventions discussed lack sufficient evidence from high-quality studies. Therefore, there is a need for comprehensive research to be conducted using evidence-based methods and tools, to enable the comparison of study results. The insights from this review might help in further research needed to establish the guidelines for effective future interventions.

Furthermore, the heterogeneity of the evidence base poses challenges for developing standardized clinical care processes for ileostomy patients. While some interventions may show promise in improving outcomes for certain subgroups of patients, the lack of high-quality evidence and consistency across studies makes it difficult to establish clear guidelines for clinical practice. Future research efforts should prioritize rigorous evaluations of interventions specifically tailored to the needs of patients with PI, with a focus on generating high-quality evidence to inform clinical decision-making.

In summary, this umbrella review emphasizes the necessity of developing standardized clinical care protocols and pathways for individuals with ileostomies, particularly those with permanent ileostomies due to CD. By tackling the gaps identified in the current literature and concentrating research efforts on producing high-quality evidence, healthcare professionals can more effectively address the unique needs of this patient population and improve their QoL.

Supplementary Information

Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 58 KB)

Authors’ contributions

Study concept and design: VJ Acquisition, analysis, and interpretation of data: VS, SKY, YY, VJ Draft of initial manuscript: VS, SKY, YY, VJ Critical revision of the manuscript for important intellectual content: All co-authors. Guarantor of Article: VJ.

Funding

The EndOTrial Consortium was funded through a grant from the Helmsley Charitable Trust.

Data Availability

No datasets were generated or analysed during the current study.

Declarations

Conflict of interest

VS, YY, MH, JAVK have none to disclose. SKY has received consulting fees from Alimentiv Inc. SS has received research grants from Pfizer. NN has received speaking/advisor fees from Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Fresenius Kabi, Innomar, Iterative Scopes, Bristol Myers Squibb, Viatris, and Ferring. CM has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche, Sanofi; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Takeda, Pendopharm, and Pfizer; royalties from Springer Publishing; research support from Ferring, Takeda, Pfizer. JH has received consulting fees from AbbVie, Alimentiv Inc, and Takeda FR is consultant to Agomab. Allergan, AbbVie, Boehringer Ingelheim, Celgene, Cowen, Falk Pharma, Genentech, Gilead, Gossamer, Guidepoint, Helmsley, Index Pharma, Jannsen, Koutif, Mestag, Metacrine, Morphic, Origo, Pfizer, Pliant, Prometheus, Receptos, RedX, Roche, Samsung, Takeda, Techlab, Theravance, Thetis, UCB and received funding from the National Institute of Health, Helmsley Charitable Trust, Crohn’s and Colitis Foundation, Rainin Foundation, UCB, Boehringer-Ingelheim, Pliant, Morphic, BMS, 89Bio. VJ has received consultancy/advisory board fees from AbbVie, Alimentiv Inc., Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Ventyx, and Vividion; and speaker’s fees from, Abbvie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, and Fresenius Kabi.

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