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

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02659176
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 61
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rectocele	Procedure: Transperineal repair with PIS; Procedure: Transperineal repair without PIS	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transperineal repair with PIS transperineal repair of anterior rectocele with limited internal sphincterotomy	Procedure: Transperineal repair with PIS; Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
Active Comparator: Transperineal repair without PIS transperineal repair of anterior rectocele only	Procedure: Transperineal repair without PIS; Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy

Outcome Measures

Primary Outcome Measures

1. Incidence of recurrence [18 months]

   Number of patients presenting with recurrent or persistent symptoms during follow up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansoura	Dakahlia	Egypt

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Mohamed Youssef, M.D, Mansoura Univesity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sameh Emile, Lecturer of surgery, Mansoura University
• ClinicalTrials.gov Identifier: NCT02659176
• Other Study ID Numbers: mansoura31
• First Posted: Jan 20, 2016
• Last Update Posted: Mar 16, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Rectocele

Study Results

No Results Posted as of Mar 16, 2016