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Completed

NCT Number: NCT02609555

TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

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.

Completed

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEM perineal rectopexy

Procedure

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

Primary outcomes

  1. Recurrence of prolapse

    Time frame: 12 months

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

Secondary outcomes

  1. Improvement of continence state

    Time frame: 12 months

    Amount of increase in continence score after surgery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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