Transvaginal Versus Transperineal Repair of Rectocele
Primary Purpose
Rectocele
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transvaginal repair
Transperineal repair
Sponsored by
About this trial
This is an interventional treatment trial for Rectocele
Eligibility Criteria
Inclusion Criteria:
- Adult female patients with anterior rectocele
Exclusion Criteria:
- Male patients.
- Combined rectocele with internal rectal prolapse.
- Anismus.
- Associated anorectal condition such as hemorrhoids and anal fissure.
- Pregnancy.
- Unwilling to participate in the trial
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transvaginal repair
Transperineal repair
Arm Description
Repair of anterior rectocele via the vagina
Repair of anterior rectocele via the perineum
Outcomes
Primary Outcome Measures
Improvement in constipation
decrease in Wexner constipation score by 25%
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03801291
Brief Title
Transvaginal Versus Transperineal Repair of Rectocele
Official Title
Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months
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
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transvaginal repair
Arm Type
Active Comparator
Arm Description
Repair of anterior rectocele via the vagina
Arm Title
Transperineal repair
Arm Type
Active Comparator
Arm Description
Repair of anterior rectocele via the perineum
Intervention Type
Procedure
Intervention Name(s)
Transvaginal repair
Intervention Description
Vaginal incision through which plication of the rectovaginal septum is done
Intervention Type
Procedure
Intervention Name(s)
Transperineal repair
Intervention Description
Perineal incision through which plication of the rectovaginal septum is done
Primary Outcome Measure Information:
Title
Improvement in constipation
Description
decrease in Wexner constipation score by 25%
Time Frame
6 and 12 months after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult female patients with anterior rectocele
Exclusion Criteria:
Male patients.
Combined rectocele with internal rectal prolapse.
Anismus.
Associated anorectal condition such as hemorrhoids and anal fissure.
Pregnancy.
Unwilling to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31996580
Citation
Balata M, Elgendy H, Emile SH, Youssef M, Omar W, Khafagy W. Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial. Dis Colon Rectum. 2020 Apr;63(4):527-537. doi: 10.1097/DCR.0000000000001595.
Results Reference
derived
Learn more about this trial
Transvaginal Versus Transperineal Repair of Rectocele
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