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.: PACTR201408000857349 Date of Approval: 17/07/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Botulinum Toxin Injection vs. Anal Myectomy in Management of Idiopathic Constipation
Official scientific title Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation in Children
Brief summary describing the background and objectives of the trial ¿Idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt ¿Numerous conservative measures were tried but many fail. ¿Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives:Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Idiopathic Constipation,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/07/2014
Actual trial start date 18/07/2014
Anticipated date of last follow up 20/11/2014
Actual Last follow-up date 20/03/2015
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised An online randomization program (http://www.randomizer.org) An online randomization program (http://www.randomizer.org) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Botulinum Toxin 3 Months 20
Experimental Group Myectomy 3 Months 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with Idiopathic constipation Hirschsprung¿s disease Anorectal malformations 2 Year(s) 10 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 09/06/2014 Surgery Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy, Faculty of Medicine Cairo 11432 Egypt
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 01/06/2014 Faculty of Medicine, Cairo University Ethical & Research Committee
Ethics Committee Address
Street address City Postal code Country
1 Ali Ibrahim St., Cairo Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success of treatment Improvement of constipation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Pediatric Hospital 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasralainy 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Pediatric Hospital 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cairo University Pediatric Hospital 1 Ali Ibrahim St, Kasralainy Cairo 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim St., kasralainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer of Pediatric Surgery
Role Name Email Phone Street address
Public Enquiries Mostafa Gad mostafagad@kasralainy.edu.eg 201002265009 1 Ali Ibrahim St., kasralainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assitant Lecturer of Pediatric Surgery
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim St., kasralainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer of Pediatric Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information