Back to resultsVertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
Primary Purpose
Rectocele
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vertical plication
Horizontal plication
Sponsored by
About this trial
This is an interventional treatment trial for Rectocele
Eligibility Criteria
Inclusion Criteria:
- Vertical plication of the rectovaginal septum was done
Exclusion Criteria:
- patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
- patients with slow transit constipation.
- patients with recurrent rectocele after previous surgery.
- patients with pre-existing FI
- patients with associated anorectal pathology.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vertical plication
Horizontal plication
Arm Description
Vertical plication of the rectovaginal septum was done
Horizontal plication of the rectovaginal septum was done
Outcomes
Primary Outcome Measures
Complete cure of symptoms
Absence of symptoms of constipation with Wexner score <2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04502953
Brief Title
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
Official Title
Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura 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
We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vertical plication
Arm Type
Active Comparator
Arm Description
Vertical plication of the rectovaginal septum was done
Arm Title
Horizontal plication
Arm Type
Active Comparator
Arm Description
Horizontal plication of the rectovaginal septum was done
Intervention Type
Procedure
Intervention Name(s)
Vertical plication
Intervention Description
Vertical plication of the rectovaginal septum was done
Intervention Type
Procedure
Intervention Name(s)
Horizontal plication
Intervention Description
Horizontal plication of the rectovaginal septum was done
Primary Outcome Measure Information:
Title
Complete cure of symptoms
Description
Absence of symptoms of constipation with Wexner score <2
Time Frame
12 months after repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Vertical plication of the rectovaginal septum was done
Exclusion Criteria:
patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
patients with slow transit constipation.
patients with recurrent rectocele after previous surgery.
patients with pre-existing FI
patients with associated anorectal pathology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
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