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
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Condition or disease | Intervention/treatment | Phase |
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: LVMR
Modified Laparoscopic Ventral Mesh Rectopexy
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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
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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 |
- 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.
- 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.
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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 |
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
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
Contact: Tao Fu, MD | 86-13720120190 | futao1975@tom.com |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |