Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 16, 2016
March 1, 2016
5 years
January 15, 2016
March 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of recurrence
Number of patients presenting with recurrent or persistent symptoms during follow up
18 months
Study Arms (2)
Transperineal repair with PIS
ACTIVE COMPARATORtransperineal repair of anterior rectocele with limited internal sphincterotomy
Transperineal repair without PIS
ACTIVE COMPARATORtransperineal repair of anterior rectocele only
Interventions
Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy
Eligibility Criteria
You may qualify if:
- Patients with anterior rectocele
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed Youssef, M.D
Mansoura Univesity
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of surgery
Study Record Dates
First Submitted
January 15, 2016
First Posted
January 20, 2016
Study Start
January 1, 2011
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
March 16, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share