Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201403000477391 Date of Approval: 25/12/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing modified Delorm's procedure with STAAR in treatment of obstructed defecation
Official scientific title Contolled randomized clinical trial comparing modified delorme's procedure with Stappled Transanal rectal resection in treatment of obstructed defecation
Brief summary describing the background and objectives of the trial Obstructed defecatio is difficult task to manage and I there is a lot of treatment failures in this work comparing two techniques used in treatment of patients who fail conservative treatment by randomly allocated patients either to modified Delorme's procedure or STARR
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Constipation, obstructed defecatio,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 05/12/2010
Actual trial start date 30/12/2010
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Modified Delorme's procedure Average 2-3 hours Surgery to remove excess rectal mucosa and resuturing using sutures through the anus 60
Control Group STARR one hour surgical procedure using 2 stappling devices to remove part of the rectal wall 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 Patients with previous anorectal surgery intestinal inertia anismus associated II/III degreegenital prolapse symptomatic cystocele were excluded. 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/12/2010 Alexandria ethical comitte
Ethics Committee Address
Street address City Postal code Country
El mery Alexandria Alexandria 21212 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome obstructed defecation score three months six months one year two year
Secondary Outcome Safety 3 months, 6 months, 1 year and 2 years
Secondary Outcome Change in quality of life score 3 months, 6 months, 1 year and 2 years
Secondary Outcome Anatomic correction of rectocele and rectal intussusception 3 months, 6 months, 1 year and 2 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Main university hospital El mery el azzarita Alexandria
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria main university hospital El mery el azzaritta Alexandria 21212 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria main university hospital el mery elazzarita Alexandria 21212 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
walid elshazly el mery el azzaritta Alexandria 21212 Egypt
Galal Abo El nagah el mery el azzaritta Alexandria 21212 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Elshazly wshazly@hotmail.com 0021221100756 el mery el azzaritta
City Postal code Country Position/Affiliation
Alexnadria 21212 Egypt Assissant Professor
Role Name Email Phone Street address
Public Enquiries israa aly israa.aly@alexmed.edu.eg 0021287740750 el mery el azzarita
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt ethical comitte responsible
Role Name Email Phone Street address
Scientific Enquiries wahid elshazly wshazly@gmail.com 0021223493268 el mery el azzaritta
City Postal code Country Position/Affiliation
Alexandria 21212 Egypt head of colorectal surgical department
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information