|
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:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201403000477391 |
|
Date of registration:
|
25/12/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Comparing modified Delorm's procedure with STAAR in treatment of obstructed defecation
|
|
Scientific title:
|
Contolled randomized clinical trial comparing modified delorme's procedure with Stappled Transanal rectal resection in treatment of obstructed defecation |
|
Date of first enrolment:
|
05/12/2010 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=477 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel: different groups receive different interventions at same time during study,Randomised,Computer generated,Sealed opaque envelopes
|
|
Phase:
|
Not Applicable
|
|
|
Contacts
|
|
Name:
|
israa
aly |
|
Address:
|
el mery el azzarita
21212
Alexandria
Egypt |
|
Telephone:
|
0021287740750 |
|
Email:
|
israa.aly@alexmed.edu.eg |
|
Affiliation:
|
ethical comitte responsible |
|
|
Name:
|
wahid
elshazly |
|
Address:
|
el mery el azzaritta
21212
Alexandria
Egypt |
|
Telephone:
|
0021223493268 |
|
Email:
|
wshazly@gmail.com |
|
Affiliation:
|
head of colorectal surgical department |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: All the patients enrolled consented to participate in the study
All the patients with an obstruction defecation score ¿12 and RI (intussusception
¿10 mm) and/or RE (extending 2 cm or more fromthe rectal wall contour) shown by CD, failure of 6 months medical therapy (1.5 l/day of water, low-fiber diet,
and 10 g/day lactulose) and biofeedback-performed for 8 weeks
Exclusion criteria: Patients with previous anorectal surgery
intestinal inertia
anismus
associated II/III degreegenital prolapse
symptomatic cystocele were excluded.
Age minimum:
18 Year(s)
Age maximum:
70 Year(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Digestive System
Constipation, obstructed defecatio
|
|
Constipation, obstructed defecatio
|
|
Digestive System
|
|
Intervention(s)
|
|
STARR
|
|
|
|
Modified Delorme's procedure
|
|
Primary Outcome(s)
|
|
obstructed defecation score
|
|
Secondary Outcome(s)
|
|
Anatomic correction of rectocele and rectal intussusception
|
|
Safety
|
|
Change in quality of life score
|
|
Source(s) of Monetary Support
|
|
Alexandria main university hospital
|
|
Ethics review
|
Status: Approved
Approval date: 09/12/2010
Contact:
alexmedethics@yahoo.com
Alexandria ethical comitte
01287740750
alexmedethics@yahoo.com
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|