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TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

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ClinicalTrials.gov Identifier: NCT02609555
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, 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.

Condition or disease Intervention/treatment Phase
Rectal Prolapse Procedure: TEM perineal rectopexy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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 : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Recurrence of prolapse [ Time Frame: 12 months ]
    Number of patients presenting with recurrent rectal prolapse within 12 months after surgery


Secondary Outcome Measures :
  1. Improvement of continence state [ Time Frame: 12 months ]
    Amount of increase in continence score after surgery



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Ages Eligible for Study:   14 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609555


Locations
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Egypt
Mansoura university hospital
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Sameh Emile, M.D Mansoura University

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Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT02609555    
Other Study ID Numbers: MansouraU26
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Keywords provided by Sameh Emile, Mansoura University:
TEM
Rectopexy
rectal prolapse
Additional relevant MeSH terms:
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Rectal Prolapse
Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse