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

Not Applicable

Completed

• Conditions: Rectocele
• Interventions: Procedure: Transperineal repair with PIS; Procedure: Transperineal repair without PIS

• Registration Number: NCT02659176
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2016-01
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-20
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transperineal repair with PIS	Transperineal repair with PIS	transperineal repair of anterior rectocele with limited internal sphincterotomy
Transperineal repair without PIS	Transperineal repair without PIS	transperineal repair of anterior rectocele only

Primary Outcome Measures

Name	Time	Method
Incidence of recurrence	18 months	Number of patients presenting with recurrent or persistent symptoms during follow up

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansoura, Dakahlia, Egypt