TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

Not Applicable

Completed

• Conditions: Rectal Prolapse
• Interventions: Procedure: TEM perineal rectopexy

• Registration Number: NCT02609555
• Lead Sponsor: Mansoura University

Brief Summary

Curvilinear incision in the postanal space, through the intersphincteric plane, insertion of Proctoscope of TEM technique and dissection till sacral promontory, insertion of mesh between the rectum and sacrum, post anal repair then anal cerclage width absorbable suture.

Detailed Description

Perineal Rectopexy is performed by an incision in the intersphincteric space followed by dissection till the sacral promontory then Proctoscope is inserted to complete the dissection .Mesh is inserted and fixed to the sacrum with laparoscopic tacker ( or can be left unfixed) then postanal repair is conducted in two layers ( levatorplasty then sphincteroplasty) and finally Ana cerclage is done with polyglactin 0 sutures

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• patients with complete or partial rectal prolapse

Exclusion Criteria

• patients unfit for surgery
• patients with previous surgery for rectal prolapse
• patients with associated anorectal pathology (e.g fistula )
• patients with constipation as a predominant symptom.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TEM perineal Rectopexy	TEM perineal rectopexy	TEM perineal rectopexy: triple repair technique , Perineal rectopexy with a polyprolene mesh assisted by TEM technique, postanal repair to close the postanak space then finally anal cerclage to hold the rectum in place for one month.

Primary Outcome Measures

Name	Time	Method
Recurrence of prolapse	12 months	Number of patients presenting with recurrent rectal prolapse within 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Improvement of continence state	12 months	Amount of increase in continence score after surgery

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansoura, Dakahlia, Egypt