- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801291
Transvaginal Versus Transperineal Repair of Rectocele
January 9, 2019 updated by: Sameh Emile, Mansoura University
Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
-
Mansourah, Dakahlia, Egypt
- Mansoura University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transvaginal repair
Repair of anterior rectocele via the vagina
|
Vaginal incision through which plication of the rectovaginal septum is done
|
Active Comparator: Transperineal repair
Repair of anterior rectocele via the perineum
|
Perineal incision through which plication of the rectovaginal septum is done
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in constipation
Time Frame: 6 and 12 months after surgery
|
decrease in Wexner constipation score by 25%
|
6 and 12 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sameh H Emile, Mansoura University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
January 7, 2019
Study Registration Dates
First Submitted
January 9, 2019
First Submitted That Met QC Criteria
January 9, 2019
First Posted (Actual)
January 11, 2019
Study Record Updates
Last Update Posted (Actual)
January 11, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- masnoura99
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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