|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02609555 |
|
Date of registration:
|
16/11/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
TEM Assisted Perineal Rectopexy in Treatment of Rectal Prolapse
|
|
Scientific title:
|
Trans-anal Endoscopic Microsurgery (TEM) Assisted Perineal Rectopexy With Postanal Repair and Anal Cerclage In Treatment of Rectal Prolapse (Novel Technique) |
|
Date of first enrolment:
|
October 2014 |
|
Target sample size:
|
7 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02609555 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Egypt
| | | | | | | |
|
Contacts
|
|
Name:
|
Sameh Emile, M.D |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mansoura University |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
14 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Rectal Prolapse
|
|
Intervention(s)
|
|
Procedure: TEM perineal rectopexy
|
|
Primary Outcome(s)
|
|
Recurrence of prolapse
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Improvement of continence state
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
MansouraU26
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|