Back to resultsLaparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
Primary Purpose
Complete Rectal Prolapse
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic ventral mesh Rectopexy
Delorme's procedure
Sponsored by
About this trial
This is an interventional treatment trial for Complete Rectal Prolapse
Eligibility Criteria
Inclusion Criteria:
- patients with complete rectal prolapse
Exclusion Criteria:
- patients who underwent previous surgery for complete rectal prolapse
- patients unfit for surgery
- patients with associated colorectal diseases or pathology
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic ventral mesh Rectopexy
delorme's procedure
Arm Description
Fixation of the rectum to the sacrum using laparoscopy and mesh
excision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures
Outcomes
Primary Outcome Measures
Recurrence of the condition
Measured by counting the number of patients with recurrence of rectal prolapse
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02601326
Brief Title
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
Official Title
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications
Detailed Description
A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications.
Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Rectal Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic ventral mesh Rectopexy
Arm Type
Active Comparator
Arm Description
Fixation of the rectum to the sacrum using laparoscopy and mesh
Arm Title
delorme's procedure
Arm Type
Active Comparator
Arm Description
excision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ventral mesh Rectopexy
Intervention Description
Laparoscopic fixation of rectum to sacral promontory using mesh
Intervention Type
Procedure
Intervention Name(s)
Delorme's procedure
Intervention Description
Transanal excision of rectal mucosa and plication of muscle layer
Primary Outcome Measure Information:
Title
Recurrence of the condition
Description
Measured by counting the number of patients with recurrence of rectal prolapse
Time Frame
18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with complete rectal prolapse
Exclusion Criteria:
patients who underwent previous surgery for complete rectal prolapse
patients unfit for surgery
patients with associated colorectal diseases or pathology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse
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