TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02609555
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Duration (Months): 19
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse	Procedure: TEM perineal rectopexy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trans-anal Endoscopic Microsurgery (TEM) Assisted Perineal Rectopexy With Postanal Repair and Anal Cerclage In Treatment of Rectal Prolapse (Novel Technique)
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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

Outcome Measures

Primary Outcome Measures

1. Recurrence of prolapse [12 months]

   Number of patients presenting with recurrent rectal prolapse within 12 months after surgery

Secondary Outcome Measures

1. Improvement of continence state [12 months]

   Amount of increase in continence score after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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: Sameh Emile, M.D, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
• ClinicalTrials.gov Identifier: NCT02609555
• Other Study ID Numbers: MansouraU26
• First Posted: Nov 20, 2015
• Last Update Posted: Mar 22, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Sameh Emile, Lecturer of general surgery, Mansoura University: TEM; Rectopexy; rectal prolapse
• Additional relevant MeSH terms: Rectal Prolapse; Prolapse

Study Results

No Results Posted as of Mar 22, 2017