Randomized Clinical Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 21, 2019; 25(11): 1421-1431
Published online Mar 21, 2019. doi: 10.3748/wjg.v25.i11.1421
Khubchandani’s procedure combined with stapled posterior rectal wall resection for rectocele
Yi Shao, Yong-Xing Fu, Qing-Fa Wang, Zhi-Qiang Cheng, Guang-Yong Zhang, San-Yuan Hu
Yi Shao, Zhi-Qiang Cheng, Guang-Yong Zhang, San-Yuan Hu, Department of General Surgery, Qilu Hospital of Shandong University, Jinan 250012, Shandong Province, China
Yong-Xing Fu, Qing-Fa Wang, Department of Neonatal Medicine, Yidu Central Hospital of Weifang, Weifang 262500, Shandong Province, China
Author contributions: Shao Y, Cheng ZQ, Zhang GY, and Hu SY designed the study, analyzed the data, and wrote the paper; Shao Y, Cheng ZQ, and Hu SY performed the surgery and treated the patients; Shao Y, Fu YX, and Wang QF did the follow-up and collected and analyzed the patient data; Hu SY approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Scientific Research of Shandong University Qilu Hospital.
Clinical trial registration statement: This study is registered at Chinese Clinical Trial Registry, and the registration number is ChiCTR1900020992.
Informed consent statement: In this study, all involved participants or their legal guardian provided written informed consent before entering the trial.
Conflict-of-interest statement: No authors of this paper have conflicting interests.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The guidelines of the CONSORT 2010 Statement have been adopted.
Open-Access: This article is an open-access article which selected by an inhouse editor and fully peer-reviewed by external reviewers. It distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: San-Yuan Hu, MD, PhD, Chief Doctor, Professor, Department of General Surgery, Qilu Hospital of Shandong University, No. 107, Wenhua Xi Road, Jinan 250012, Shandong Province, China. husanyuan1962@hotmail.com
Telephone: +86-531-82166351 Fax: +86-531-82166351
Received: January 30, 2019
Peer-review started: January 30, 2019
First decision: February 13, 2019
Revised: February 17, 2019
Accepted: February 22, 2019
Article in press: February 22, 2019
Published online: March 21, 2019
Research background

Obstructed defecation syndrome (ODS) has a serious influence on health and life quality of patients. Rectocele is one of the main causes of ODS, which has an approximate incidence of 30%-71%. Multiple procedures have been performed to treat rectocele, but no one has been considered as the gold-standard treatment.

Research motivation

Stapled transanal rectal resection (STARR) has been quite popular in treating rectocele for its simpleness. However, debate on STARR has never stopped. Opponents doubted its effectiveness in anterior wall repair and declared that multiple serious postoperative complications occurred. Khubchandani performed his procedure for rectocele with a satisfying effect, but it did not take rectal prolapse into consideration and may potentially induce rectal prolapse in posterior rectal wall. Therefore, we combined Khubchandani’s procedure and stapled posterior rectal wall resection together.

Research objectives

In this study, we evaluated the efficacy and safety of a novel rectocele repair which combined Khubchandani’s procedure with stapled posterior rectal wall resection. The results of the study will guide the treatment for rectocele in future.

Research methods

From January 2014 to January 2017, 93 patients were recruited into our randomized clinical trial and divided into two different groups in a randomized manner. Forty-two patients (group A) underwent Khubchandani’s procedure with stapled posterior rectal wall resection (KSPRWR) and 51 patients (group B) underwent the stapled transanal rectal resection (STARR) procedure. Follow-up was performed at 1, 3, 6, and 12 mo after the operation. Preoperative and postoperative ODS scores and depth of rectocele, postoperative complications, blood loss, and hospital stay of each patient were documented. All data were analyzed statistically to evaluate the efficiency and safety of our procedure.

Research results

No significant differences were found in blood loss, hospital stay, or operative time. Compared with preoperative ODS scores and rectocele depth, postoperative ODS scores and rectocele depth in the two groups were statistically lower, which proved the effectiveness of our procedure. There were significant differences when comparing the ODS score and rectocele depth 1 year after operation, which were significantly lower in group A than in group B, thus indicating that group A might have better outcomes in future.

Research conclusions

KSPRWR is an effective and safe procedure with minor trauma, short hospital stay, and low cost for rectocele treatment, especially for rectocele combined with rectal prolapse. It should be considered as an alternative operation for rectocele.

Research perspectives

A long-term follow-up, a larger number of patients, and a multiple center clinical trial are expected in the future to further prove the effectiveness and safety of this procedure.