Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
Primary Purpose
Rectocele
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transperineal repair with PIS
Transperineal repair without PIS
Sponsored by
About this trial
This is an interventional treatment trial for Rectocele
Eligibility Criteria
Inclusion Criteria:
- Patients with anterior rectocele
Exclusion Criteria:
- Pregnant females
- Rectocele with pelvic organ prolapse
- Any patient with previous anorectal surgery
- Pudendal nerve neuropathy
- Anal fistula and sepsis
- Patients with sphincter defect proved by endo-anal sonography
- Patients proved to have colonic inertia either by colon transit time and/or history
- Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
- Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transperineal repair with PIS
Transperineal repair without PIS
Arm Description
transperineal repair of anterior rectocele with limited internal sphincterotomy
transperineal repair of anterior rectocele only
Outcomes
Primary Outcome Measures
Incidence of recurrence
Number of patients presenting with recurrent or persistent symptoms during follow up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02659176
Brief Title
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
Official Title
Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.
Detailed Description
Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transperineal repair with PIS
Arm Type
Active Comparator
Arm Description
transperineal repair of anterior rectocele with limited internal sphincterotomy
Arm Title
Transperineal repair without PIS
Arm Type
Active Comparator
Arm Description
transperineal repair of anterior rectocele only
Intervention Type
Procedure
Intervention Name(s)
Transperineal repair with PIS
Intervention Description
Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
Intervention Type
Procedure
Intervention Name(s)
Transperineal repair without PIS
Intervention Description
Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy
Primary Outcome Measure Information:
Title
Incidence of recurrence
Description
Number of patients presenting with recurrent or persistent symptoms during follow up
Time Frame
18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with anterior rectocele
Exclusion Criteria:
Pregnant females
Rectocele with pelvic organ prolapse
Any patient with previous anorectal surgery
Pudendal nerve neuropathy
Anal fistula and sepsis
Patients with sphincter defect proved by endo-anal sonography
Patients proved to have colonic inertia either by colon transit time and/or history
Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Youssef, M.D
Organizational Affiliation
Mansoura Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
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