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Trial record 7 of 9 for:    Recruiting, Not yet recruiting, Available Studies | "Rectal Prolapse"

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 : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Tao Fu, Renmin Hospital of Wuhan University

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 Rectocele Rectal Prolapse Procedure: Laparoscopic Ventral Mesh Rectopexy Procedure: Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LVMR
Laparoscopic Ventral Mesh Rectopexy
Procedure: Laparoscopic Ventral Mesh Rectopexy
This group will undergo laparoscopic ventral mesh rectopexy alone

Experimental: LVMR with STARR
Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Procedure: Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
This group will undergo laparoscopic ventral mesh rectopexy combined with stapled trans-anal rectal resection




Primary Outcome Measures :
  1. 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.


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

  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, 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
Criteria

Inclusion Criteria:

  • Patients affected by obstructed defecation with a minimum ODS score of 10
  • Have rectocele and/or rectal prolapse confirmed by defecography
  • 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
  • Have an American Society of Anesthesiologists (ASA) score of no more than 3

Exclusion Criteria:

  • Full-thickness prolapse
  • Slow transit constipation
  • Anismus
  • Pelvic organ prolapse
  • Previous rectal or anal surgery
  • Recto-vaginal fistula
  • Pregnancy
  • Prior pelvic radiotherapy
  • Significant rectal fibrosis
  • Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
  • Perineal infection

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

Locations
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

Responsible Party: Tao Fu, Head of Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier: NCT03060330     History of Changes
Other Study ID Numbers: LVMRSTARRODS2017
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
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

Additional relevant MeSH terms:
Rectal Prolapse
Syndrome
Constipation
Prolapse
Rectocele
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse
Hernia