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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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectocele

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 9, 2019
Last Updated
January 9, 2019
Sponsor
Mansoura University
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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

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Transvaginal Versus Transperineal Repair of Rectocele

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