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.: PACTR202206695979359 Date of Approval: 02/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Post-circumcision pain in Pediatrics
Official scientific title Randomized Controlled Trial Comparing Post-operative Pain Outcome Between Suture and Tissue Glue Wound Apposition Post Circumcision in the Pediatric Age Group
Brief summary describing the background and objectives of the trial Sutures and Glue have both been used for wound closure in circumcision. Several studies have been done internationally comparing the two techniques while exploring various outcomes. Pain as an outcome has been poorly researched. The background postulate of this study is that pain is a product of ischemia caused locally by the sutures. The study thus sets out to compare differences in pain between these two interventions. Primary objective is to compare post-operative pain between the two interventions. The secondary objectives are to establish the difference in post-operative bleeding, wound dehiscence and surgery duration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Tissue glue for circumcision wound apposition
Anticipated trial start date 08/09/2021
Actual trial start date
Anticipated date of last follow up 07/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tissue Glue During wound closure Tissue glue for wound apposition 33
Control Group Suture During wound closure Suture for wound apposition 33 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male Children between 2 - 12 years Consent to randomisation Bleeding Disorders Congenital malformations of the male genitalia Patients undergoing other procedure plus circumcision Known adverse reactions or contraindications to the analgesics, local anaesthesia or tissue glue being used Language barrier leading to inability to apply the pain assessment tool Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 12 Year(s) Male
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 08/09/2021 Aga Khan University Institutional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue Nairobi 30270-001 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-operative pain 24 and 48 hours
Secondary Outcome Difference in bleeding rates One week
Secondary Outcome Wound dehiscence One week
Secondary Outcome Duration of surgery Immediately after the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital 3rd Parklands Avenue Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University Hospital Grants Office 3rd Parklands Avenue Nairobi 30270-001 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University Grants Office 3rd Parklands Avenue Nairobi Kenya University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stanley Mugambi stanley.mugambi@aku.edu +254725103850 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya Paediatric Surgeon
Role Name Email Phone Street address
Public Enquiries Wangui Thanga wangui.thanga@aku.edu +254721380886 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya Paediatric Anaesthetist
Role Name Email Phone Street address
Scientific Enquiries Happiness Obare happyobare@gmail.com +254727408944 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi Kenya General Surgery Resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data available will comprise data that underlies the results reported in this article after de-identification. Including tables and charts Study Protocol Data shall be available following publication. The end date shall be determined following publication. Data will be available for anyone who wishes to access the data within the stipulated period of availability.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not Applicable No
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