==== Front Ann Saudi MedAnn Saudi MedAnnals of Saudi Medicine0256-49470975-4466King Faisal Specialist Hospital and Research Centre 10.5144/0256-4947.2013.511asm-5-511LettersFertility outcome of using intrauterine balloon stenting during resectoscopic septum division Ghobadifar Mohamed Amin From the Department of Student Reseach Committee, Medicine School, Jahrom University of Medical Sciences, Jahrom, IranCorrespondence: Dr. Mohamed Amin Ghobadifar, Department of Student Reseach Committee, Medicine School, Jahrom University of Medical Sciences, Motahari Avenue, Iran, Jahrom 193, Iran, Amin_m505@yahoo.comSep-Oct 2013 33 5 511 512 Copyright © 2013, Annals of Saudi Medicine2013This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. ==== Body To the Editor: With a great interest, I have read a recently published article in Annals of Saudi Medicine by Basim Fuad Abu Rafea et al, entitled “Fertility and pregnancy outcomes following resectoscopic septum division with and without intrauterine balloon stenting: a randomized pilot study”.1 The authors skillfully declared an interesting investigation about the benefits of intrauterine balloon splinting/Foley catheter after resectoscopic septum division on fertility, septum reformation, and pregnancy outcomes. They concluded that “Following resectoscopic septum division with monopolar knife electrode, splinting the uterine cavity with Foley catheter provided no advantage in clinical pregnancy rate, septum reformation, and pregnancy outcomes.” Although this issue is a challenging topic in fertility and pregnancy, but there are some concerns in the mentioned study that undermine the reported findings to make a definite conclusion. The number of cases included in the study is one of the most discussed queries. I can declare that if the difference between the 2 studied groups (balloon or no balloon) was not significant, it could due to the small amount of sample size that did not allow drawing any definitive conclusions. Thus, to rule out this query and to compensate any refusal of data, the authors should estimate the “power” of their study. The authors randomized the patients into the 2 studied groups, and no significant difference in terms of age, parity, and comorbidities were reported. However, menopausal status, race, age of menopause, menopausal hormone therapy, occupation, marital status, OCP use, and so on, should be distributed equally between the 2 groups before drawing any conclusion, which was not considered by the authors in this study. The authors expertly excluded those patients who received preoperative endometrial thinning, adjunctive postoperative hormone therapy, or antibiotic prophylaxis, but they seemed to be inadequate as exclusion criteria in the clinical study. The authors did not declare if they excluded pregnant women, patients with active pelvic infection, patients allergic to radiographic contrast media, and patients with or without known endometrial or cervical cancer.2,3 Therefore, the mentioned criteria should be considered by the authors. A participation fellow chart is mandatory for clinical studies based on the CONSORT (Consolidated Standards of Reporting Trials) statement,4,5 but it was missing in this study. Moreover, in the ”Methods” section, the statistical analysis is poorly presented and the power analysis is incomplete. Moreover, the chosen proportion for significant or not significant difference in fertility and pregnancy outcomes should be mentioned. Finally, the secondary outcomes of the resectoscopic procedure, such as fever, increasing abdominal pain, heavy vaginal bleeding, foul smelling vaginal discharge,6 and so on, should be mentioned in the results by the authors. We suggest that a study with accurate and powerful methods according to CONSORT statement is required for this topic. However, the authors acknowledged to the heterogeneity of their study population as a limitation. Therefore, future studies with a homogeneous sample, well-characterized controls, and cases that increase the sensitivity of detecting the associations should be considered necessary to exclude this problem. Acknowledgments I acknowledge the authorities of Jahrom University of Medical Sciences for financial support. ==== Refs REFERENCES 1 Abu BF Vilos GA Oraif AM Power SG Cains JH Vilos AG Fertility and pregnancy outcomes following resectoscopic septum division with and without intrauterine balloon stenting: a randomized pilot study Ann Saudi Med 2013 33 1 34 9 23458938 2 Cicinelli E Hysteroscopy without anesthesia: review of recent literature Journal of Minimally Invasive Gynecology 2010 17 6 703 8 20955981 3 Palmer SN Greenberg JA Transcervical sterilization: a comparison of Essure® permanent birth control system and Adiana® permanent contraception system Reviews in Obstetrics and Gynecology 2009 2 2 84 19609402 4 Schulz KF Altman DG Moher D CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials J Clin Epidemiol 2010 63 8 834 40 20346629 5 Begg C Cho M Eastwood S Horton R Moher D Olkin I Improving the quality of reporting of randomized controlled trials. The CONSORT statement Jama 1996 276 8 637 9 8773637 6 Garuti G Luerti M Hysteroscopic bipolar surgery: a valuable progress or a technique under investigation? Curr Opin Obstet Gynecol 2009 21 4 329 34 19512926