Trial record 2 of 12 for:    rectal prolapse | Open Studies | Exclude Unknown

TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Mansoura University
Information provided by (Responsible Party):
Sameh Emile, Mansoura University Identifier:
First received: November 16, 2015
Last updated: November 18, 2015
Last verified: November 2015
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 Intervention
Rectal Prolapse
Procedure: TEM perineal rectopexy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Recurrence of prolapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients presenting with recurrent rectal prolapse within 12 months after surgery

Secondary Outcome Measures:
  • Improvement of continence state [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Amount of increase in continence score after surgery

Estimated Enrollment: 20
Study Start Date: October 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02609555

Contact: Sameh Emile, M.D

Mansoura university hospital Recruiting
Mansoura, Dakahlia, Egypt
Contact: Sameh Emile, M.D   
Sponsors and Collaborators
Mansoura University
Principal Investigator: Sameh Emile, M.D Mansoura University
  More Information

No publications provided

Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University Identifier: NCT02609555     History of Changes
Other Study ID Numbers: MansouraU26
Study First Received: November 16, 2015
Last Updated: November 18, 2015
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
rectal prolapse

Additional relevant MeSH terms:
Rectal Prolapse
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Rectal Diseases processed this record on November 25, 2015