NCT02609555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

November 16, 2015

Last Update Submit

March 21, 2017

Conditions

Rectal Prolapse

Keywords

TEMRectopexyrectal prolapse

Outcome Measures

Primary Outcomes (1)

  • Recurrence of prolapse

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

    12 months

Secondary Outcomes (1)

  • Improvement of continence state

    12 months

Study Arms (1)

TEM perineal Rectopexy

EXPERIMENTAL

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

TEM perineal rectopexyPROCEDURE

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

TEM perineal Rectopexy

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with complete or partial rectal prolapse

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Sameh Emile, M.D

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 20, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

EG(1)