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NCT02659176 Clinical Trial

Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele

Rectocele Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02659176
Other study ID # mansoura31
Secondary ID
Status Completed
Phase N/A
First received January 15, 2016
Last updated March 14, 2016
Start date January 2011
Est. completion date February 2016

Study information
Verified date March 2016
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Transperineal repair with PIS
Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
• Transperineal repair without PIS
Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy

Locations
Country Name City State
Egypt Mansoura university hospital Mansoura Dakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of recurrence Number of patients presenting with recurrent or persistent symptoms during follow up 18 months No
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