Transvaginal Versus Transperineal Repair of Rectocele
Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT03801291
Collaborator
(none)
64
1
2
33.2
1.9
Study Details
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
Actual Study Start Date
:
Apr 1, 2016
Actual Primary Completion Date
:
Jul 1, 2018
Actual Study Completion Date
:
Jan 7, 2019
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Transvaginal repair Repair of anterior rectocele via the vagina |
Procedure: Transvaginal repair
Vaginal incision through which plication of the rectovaginal septum is done
|
Active Comparator: Transperineal repair Repair of anterior rectocele via the perineum |
Procedure: Transperineal repair
Perineal incision through which plication of the rectovaginal septum is done
|
Outcome Measures
Primary Outcome Measures
- Improvement in constipation [6 and 12 months after surgery]
decrease in Wexner constipation score by 25%
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mansoura university hospital | Mansourah | Dakahlia | Egypt |
Sponsors and Collaborators
- Mansoura University
Investigators
- Principal Investigator: Sameh H Emile, Mansoura University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sameh Emile,
Lecturer of general surgery,
Mansoura University
ClinicalTrials.gov Identifier:
NCT03801291
Other Study ID Numbers:
- masnoura99
First Posted:
Jan 11, 2019
Last Update Posted:
Jan 11, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: