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

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ClinicalTrials.gov Identifier: NCT03060330
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Tao Fu, Renmin Hospital of Wuhan University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obstructive Defecation Syndrome Chronic Constipation Rectal Prolapse Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LVMR
Modified Laparoscopic Ventral Mesh Rectopexy
 Procedure: Modified Laparoscopic Ventral Mesh Rectopexy
This group will undergo modified laparoscopic ventral mesh rectopexy alone
Experimental: LVMR with STARR
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
 Procedure: Modified 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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the ODS score (ODS-S) [ Time Frame: Baseline and 12 months after surgery ]
    The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 0 to 12 months after surgery ]
    Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.

  2. Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL) [ Time Frame: Baseline, 1, 3, 6, and 12 months after surgery ]
    This is a measure of efficacy.

  3. Changes in Health-Related Quality of Life [ Time Frame: Baseline, 1, 3, 6, and 12 months after surgery ]
    SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.

  4. Changes in Cleveland Clinic Fecal Incontinence Score (CCFI) [ Time Frame: Baseline, 1, 3, 6, and 12 months after surgery ]
    This is a measure of efficacy.

  5. Changes in Fecal Incontinence Quality of Life Scale (FIQoL) [ Time Frame: Baseline, 1, 3, 6, and 12 months after surgery ]
    This is a measure of efficacy.

  6. Radiological outcome as assessed by defecography [ Time Frame: Baseline and 12 months after surgery ]
    This is a measure of efficacy.

  7. Changes in the ODS score (ODS-S) [ Time Frame: Baseline, 1, 3, 6, and 12 months after surgery ]
    This is a measure of efficacy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060330


Contacts
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Contact: Tao Fu, MD 86-13720120190 futao1975@tom.com

Locations
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China, Hubei
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University Recruiting
Wuhan, Hubei, China, 430060
Contact: Tao Fu, MD    86-13720120190    futao1975@tom.com   
Sponsors and Collaborators
Renmin Hospital of Wuhan University
More Information
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Responsible Party: Tao Fu, Chief of Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT03060330    
Other Study ID Numbers: LVMRSTARRODS2017
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Prolapse
Syndrome
Constipation
Prolapse
Disease
Pathologic Processes
Signs and Symptoms, Digestive
 Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse