TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

Rectal Prolapse Clinical Trial

Official title:

Trans-anal Endoscopic Microsurgery (TEM) Assisted Perineal Rectopexy With Postanal Repair and Anal Cerclage In Treatment of Rectal Prolapse (Novel Technique)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609555
• Other study ID #: MansouraU26
• Status: Completed
• Phase: N/A
• First received: November 16, 2015
• Last updated: March 21, 2017
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• TEM perineal rectopexy
perineal rectopexy using polyprolene mesh assisted by TEM technique and special proctoscope postanal repair in two layers to narrow the postanal space anal cerclage with absorbable sutures

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	Recurrence of prolapse	Number of patients presenting with recurrent rectal prolapse within 12 months after surgery	12 months
Secondary	Improvement of continence state	Amount of increase in continence score after surgery	12 months