Back to resultsTEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse
Primary Purpose
Rectal Prolapse
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TEM perineal rectopexy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Prolapse focused on measuring TEM, Rectopexy, rectal prolapse
Eligibility Criteria
Inclusion Criteria:
- patients with complete or partial rectal prolapse
Exclusion Criteria:
- patients unfit for surgery
- patients with previous surgery for rectal prolapse
- patients with associated anorectal pathology (e.g fistula )
- patients with constipation as a predominant symptom.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TEM perineal Rectopexy
Arm Description
TEM perineal rectopexy: triple repair technique , Perineal rectopexy with a polyprolene mesh assisted by TEM technique, postanal repair to close the postanak space then finally anal cerclage to hold the rectum in place for one month.
Outcomes
Primary Outcome Measures
Recurrence of prolapse
Number of patients presenting with recurrent rectal prolapse within 12 months after surgery
Secondary Outcome Measures
Improvement of continence state
Amount of increase in continence score after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02609555
Brief Title
TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse
Official Title
Trans-anal Endoscopic Microsurgery (TEM) Assisted Perineal Rectopexy With Postanal Repair and Anal Cerclage In Treatment of Rectal Prolapse (Novel Technique)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (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
Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.
Detailed Description
Perineal Rectopexy is performed by an incision in the intersphincteric space followed by dissection till the sacral promontory then Proctoscope is inserted to complete the dissection .Mesh is inserted and fixed to the sacrum with laparoscopic tacker ( or can be left unfixed) then postanal repair is conducted in two layers ( levatorplasty then sphincteroplasty) and finally Ana cerclage is done with polyglactin 0 sutures
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
Keywords
TEM, Rectopexy, rectal prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEM perineal Rectopexy
Arm Type
Experimental
Arm Description
TEM perineal rectopexy: triple repair technique , Perineal rectopexy with a polyprolene mesh assisted by TEM technique, postanal repair to close the postanak space then finally anal cerclage to hold the rectum in place for one month.
Intervention Type
Procedure
Intervention Name(s)
TEM perineal rectopexy
Intervention Description
perineal rectopexy using polyprolene mesh assisted by TEM technique and special proctoscope postanal repair in two layers to narrow the postanal space anal cerclage with absorbable sutures
Primary Outcome Measure Information:
Title
Recurrence of prolapse
Description
Number of patients presenting with recurrent rectal prolapse within 12 months after surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement of continence state
Description
Amount of increase in continence score after surgery
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with complete or partial rectal prolapse
Exclusion Criteria:
patients unfit for surgery
patients with previous surgery for rectal prolapse
patients with associated anorectal pathology (e.g fistula )
patients with constipation as a predominant symptom.
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
Learn more about this trial
TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse
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