Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients affected by obstructed defecation with a minimum ODS score of 10

• External rectal prolapse or high-grade internal rectal prolapse

• Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement

• Have experienced ODS symptoms for at least 12 months prior to enrollment

• Failure of at least 6 months of medical therapy

• American Society of Anesthesiologists (ASA) score of no more than 3

Locations
Other Locations
China
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Contact Information
Primary
Tao Fu, MD
futao1975@tom.com
86-13720120190
Time Frame
Start Date: 2017-04-26
Estimated Completion Date: 2026-04
Participants
Target number of participants: 126
Treatments
Experimental: LVMR
Modified Laparoscopic Ventral Mesh Rectopexy
Experimental: LVMR with STARR
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Related Therapeutic Areas
Sponsors
Leads: Renmin Hospital of Wuhan University

This content was sourced from clinicaltrials.gov