RecruitingNot ApplicableNCT03060330

Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

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


Sponsor

Renmin Hospital of Wuhan University

Enrollment

126 participants

Start Date

Apr 26, 2017

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

  • 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

Exclusion Criteria14

  • Slow transit constipation
  • Anismus resistant to conventional treatment
  • No demonstrable pelvic anatomical problem
  • Previous rectal or anal surgery
  • Recto-vaginal fistula
  • Pregnancy
  • Previous pelvic radiotherapy
  • Severe proctitis or significant rectal fibrosis
  • Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
  • Perineal infection
  • High-grade endometriosis
  • Morbid obesity
  • A hostile abdomen
  • Psychological instability

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Interventions

PROCEDUREModified Laparoscopic Ventral Mesh Rectopexy

This group will undergo modified laparoscopic ventral mesh rectopexy alone

PROCEDUREModified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection

This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection


Locations(1)

Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University

Wuhan, Hubei, China

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NCT03060330


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