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.: PACTR201602001480323 Date of Approval: 22/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
Official scientific title Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception
Brief summary describing the background and objectives of the trial Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception. Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Digestive System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/04/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 01/03/2016
Actual Last follow-up date 01/03/2016
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 100
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 REDCap Software Software Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hydrocortisone 10 mg/kg with Resuscitation before attempting reduction Single Dose With Resuscitation before attempting reduction 50
Control Group Saline 100 ml IV single injection with Resuscitation before attempting first reduction Single Dose 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Infantile Intussusception Peritonitis Pneumoperitoneum Morbid patients 3 Month(s) 4 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 01/04/2015 Cairo University Surgery Dept. Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Cairo University Faculty of Medicine Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success of Pneumatic Reduction Comparing number of Successful Pneumatic Reductions in both groups
Secondary Outcome Reducing number of trials of Pneumatic Reduction Comparing average number of Pneumatic Reduction trials between both groups
Secondary Outcome Reducing complications Comparing number of complications in both groups
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Pediatric Surgery Dept 1 Ali Ibrahim St. Kasr Al Ainy Cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Faculty of Medicine 1 Ali Ibrahim St. Kasr Al Ainy Cairo 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Pediatric Surgery Dept 1 Ali Ibrahim St Kasr Al Ainy Cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cairo University Pediatric Surgery Dept Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Gad mostafagad@kasralainy.edu.eg 201002265009 1 Ali Ibrahim St. Kasr Al Ainy
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Lecturer of Pediatric Surgery
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Elfiky mfiky@kasralainy.edu.eg 201001557755 1 Ali Ibrahim St. Kasr Al Ainy
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