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.: PACTR201902572603348 Date of Approval: 14/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Is Peritoneal Drainage Necessary after Laparoscopic Appendectomy for Complicated Acute Appendicitis in Children
Official scientific title Is Peritoneal Drainage Necessary after Laparoscopic Appendectomy for Complicated Acute Appendicitis in Children
Brief summary describing the background and objectives of the trial To evaluate the necessity of intra-abdominal drain after laparoscopic surgical management of complicated appendicitis in children. To compare the effectiveness of peritoneal irrigation and peritoneal drainage with a silicon tube in complicated appendicitis in children. Primary outcome is surgical site infections as intra-abdominal infections or wound infections. Secondary outcomes are morbidity, hospital stay and hospital costs.
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 Treatment: Surgery
Anticipated trial start date 02/02/2019
Actual trial start date 02/02/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Active, not 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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group to put intraperitoneal drain till no fluid comes out in drain to put intraperitoneal drain 20 Active-Treatment of Control Group
Experimental Group no intraperitoneal drain nil no intraperitoneal drain 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pediatric patients aged up to 18 years from both sex who about to undergo emergency laparoscopic appendectomy for complicated appendicitis (appendicular mass, appendicular abscess, appendicular gangrene, appendicular perforation or free pus in the peritoneum). • Patients with simple non complicated appendicitis. • Patients with associated other diseases (severe cardiac or respiratory diseases). • Patients unfit for laparoscopy. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 18 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 30/01/2019 Tanta University Faculty of Medicie Research Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
El-Geish st. Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome surgical site infections as intra-abdominal infections or wound infections. 1 week
Secondary Outcome Secondary outcomes are morbidity, hospital stay and hospital costs. 2 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El-Geish st. Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Shehata El-Geish st, Faculty of Medicine, Tanta University, Tanta Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Faculty of Medicine El-Geish st. Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Hisham Almohmady El-Geish st Tanta 31527 Egypt
Essam Elhalaby El-Geish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Shehata Mohamedshehata81@hotmail.com 00201114330114 El-Geish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of pediatric surgery Tanta University Hospital Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Ahmed Nofl ahmed.nofal@med.tanta.edu.eg 00201111447789 El-Geish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Head of general surgery department faculty of medicine Tanta university
Role Name Email Phone Street address
Public Enquiries Amany Faheem amanyfaheem2011@yahoo.com 00201008372249 El-Geish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anaesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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