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CompletedNCT02609555Updated Mar 22, 2017

TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse

An interventional study of TEM perineal rectopexy in Rectal Prolapse, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
14 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Rectal Prolapse

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Keywords

  • TEM
  • Rectopexy
  • rectal prolapse
03

In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's enrollment of 7 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with complete or partial rectal prolapse

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureTEM 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

06

What researchers measure

Primary outcomes

  1. Recurrence of prolapse

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

    Time frame: 12 months

Secondary outcomes

  1. Improvement of continence state

    Amount of increase in continence score after surgery

    Time frame: 12 months

07

Study locations

1 site
  • Mansoura university hospital
    Mansoura, Dakahlia, Egypt
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 16, 2015
First posted
Nov 20, 2015
Start
Oct 2014
Primary completionActual
May 2016
CompletionActual
May 2016
Last update
Mar 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02609555
Responsible party
Sameh Emile (Lecturer of general surgery, Mansoura University) — Principal investigator
First posted
Nov 20, 2015
Start date
Oct 2014
Primary completion
May 2016
Completion
May 2016
Last update
Mar 22, 2017

Study contacts

Sameh Emile, M.D
principal investigator · Mansoura University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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