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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

Tracking Information
First Submitted Date  ICMJE February 14, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date March 15, 2022
Actual Study Start Date  ICMJE April 26, 2017
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2017)		 Changes in the ODS score (ODS-S) and Patient Assessment of Constipation- Quality of Life score (PAC-QoL) [ Time Frame: Baseline, 1 month after surgery ]
The primary outcome measure will be the percent change from baseline in the sum of ODS-S and PAC-QoL at 1 month after the surgery. This measures the symptomatic improvement in ODS.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Radiological outcome as assessed by defecography [ Time Frame: Baseline and 12 months after surgery ]
    This is a measure of efficacy.
  • Changes in the ODS score (ODS-S) [ Time Frame: Baseline, 1, 3, 6, and 12 months after surgery ]
    This is a measure of efficacy.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2017)
  • Changes in the ODS score (ODS-S) [ Time Frame: Baseline, 1, 3, 6 and 12 months after surgery ]
    This is a measure of efficacy.
  • 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.
  • 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.
  • 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.
  • 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.
  • Radiological outcome as assessed by defecography [ Time Frame: Baseline, 6 and 12 months after surgery ]
    This is a measure of efficacy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
Official Title  ICMJE Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Defecation Syndrome
  • Chronic Constipation
  • Rectal Prolapse
Intervention  ICMJE
  • Procedure: Modified Laparoscopic Ventral Mesh Rectopexy
    This group will undergo modified laparoscopic ventral mesh rectopexy alone
  • 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
Study Arms  ICMJE
  • Experimental: LVMR
    Modified Laparoscopic Ventral Mesh Rectopexy
    Intervention: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy
  • Experimental: LVMR with STARR
    Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
    Intervention: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2019)		 126
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2017)		 40
Estimated Study Completion Date  ICMJE April 2026
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tao Fu, MD 86-13720120190 futao1975@tom.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03060330
Other Study ID Numbers  ICMJE LVMRSTARRODS2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tao Fu, Renmin Hospital of Wuhan University
Original Responsible Party Tao Fu, Renmin Hospital of Wuhan University, Head of Department of Gastrointestinal Surgery II
Current Study Sponsor  ICMJE Renmin Hospital of Wuhan University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Renmin Hospital of Wuhan University
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP