Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
Primary Purpose
Obstructive Defecation Syndrome, Chronic Constipation, Rectal Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Modified Laparoscopic Ventral Mesh Rectopexy
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Defecation Syndrome
Eligibility 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
Sites / Locations
- Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LVMR
LVMR with STARR
Arm Description
Modified Laparoscopic Ventral Mesh Rectopexy
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Outcomes
Primary Outcome Measures
Changes in the ODS score (ODS-S)
The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.
Secondary Outcome Measures
Postoperative complications
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)
This is a measure of efficacy.
Changes in Health-Related Quality of Life
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)
This is a measure of efficacy.
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)
This is a measure of efficacy.
Radiological outcome as assessed by defecography
This is a measure of efficacy.
Changes in the ODS score (ODS-S)
This is a measure of efficacy.
Full Information
NCT ID
NCT03060330
First Posted
February 14, 2017
Last Updated
March 12, 2022
Sponsor
Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT03060330
Brief Title
Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Defecation Syndrome, Chronic Constipation, Rectal Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LVMR
Arm Type
Experimental
Arm Description
Modified Laparoscopic Ventral Mesh Rectopexy
Arm Title
LVMR with STARR
Arm Type
Experimental
Arm Description
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Intervention Type
Procedure
Intervention Name(s)
Modified Laparoscopic Ventral Mesh Rectopexy
Intervention Description
This group will undergo modified laparoscopic ventral mesh rectopexy alone
Intervention Type
Procedure
Intervention Name(s)
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Intervention Description
This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection
Primary Outcome Measure Information:
Title
Changes in the ODS score (ODS-S)
Description
The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.
Time Frame
Baseline and 12 months after surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.
Time Frame
0 to 12 months after surgery
Title
Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)
Description
This is a measure of efficacy.
Time Frame
Baseline, 1, 3, 6, and 12 months after surgery
Title
Changes in Health-Related Quality of Life
Description
SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.
Time Frame
Baseline, 1, 3, 6, and 12 months after surgery
Title
Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)
Description
This is a measure of efficacy.
Time Frame
Baseline, 1, 3, 6, and 12 months after surgery
Title
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)
Description
This is a measure of efficacy.
Time Frame
Baseline, 1, 3, 6, and 12 months after surgery
Title
Radiological outcome as assessed by defecography
Description
This is a measure of efficacy.
Time Frame
Baseline and 12 months after surgery
Title
Changes in the ODS score (ODS-S)
Description
This is a measure of efficacy.
Time Frame
Baseline, 1, 3, 6, and 12 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Fu, MD
Phone
86-13720120190
Email
futao1975@tom.com
Facility Information:
Facility Name
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Fu, MD
Phone
86-13720120190
Email
futao1975@tom.com
12. IPD Sharing Statement
Plan to Share IPD
No
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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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