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.: PACTR201901796143495 Date of Registration: 18/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Combined Laparoscopic Splenectomy and Cholecystectomy in Pediatric Patients through the same trocar sites for laparoscopic splenectomy, prospective study
Official scientific title Combined Laparoscopic Splenectomy and Cholecystectomy in Pediatric Patients
Brief summary describing the background and objectives of the trial Aim of this study is to evaluate the efficacy, safety and feasibility of combined laparoscopic splenectomy and cholecystectomy for treating pediatric patients. Our primary outcome will be the safety of combined laparoscopic splenectomy and cholecystectomy through the same ports for splenectomy without the need for additional ports for cholecystectomy, while the secondary outcome includes the operative time, amount of intra-operative blood loss, operative or post-operative complications, hospital stay, and portal vein thrombosis
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2018
Actual trial start date 01/12/2018
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 30/11/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined laparoscopic splenectomy and cholecystectomy in pediatrics through same trocars no 1 year to evaluate the efficacy, safety and feasibility of combined laparoscopic splenectomy and cholecystectomy for treating pediatric patients. 30
Control Group laparoscopic splenectomy no 1 year laparoscopic splenectomy 30 Active-Treatment of Control Group
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 in need for splenectomy and had cholelithiasis will be included in this study. Traumatic splenectomy will be excluded. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(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 18/12/2018 Research Ethics Committee Quality Assurance Unit Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El-Geish Street Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary outcome will be the safety of combined laparoscopic splenectomy and cholecystectomy through the same ports for splenectomy without the need for additional ports for cholecystectomy. 1 year
Secondary Outcome The secondary outcome includes the operative time, amount of intra-operative blood loss, operative or post-operative complications, hospital stay, and portal vein thrombosis 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El-Geish Street Tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University Hospital El-Geish Street Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospital El-Geish Street Tanta 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Shehata mohamedshehata81@hotmail.com 00201114330114 El-Geish Street
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer General Surgery Department Tanta University Hospital Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Amany Faheem amanyfaheem2011@yahoo.com 00201008372249 El-Geish Street
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Doctor Tanta University Hospital Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmed Nofl ahmed.nofal@med.tanta.edu.eg 00201111447789 El-Geish Street
City Postal code Country Position/Affiliation
Tanta 31257 Egypt professor and head of general surgery department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Aim of this study is to evaluate the efficacy, safety and feasibility of combined laparoscopic splenectomy and cholecystectomy for treating pediatric patients. Our primary outcome will be the safety of combined laparoscopic splenectomy and cholecystectomy through the same ports for splenectomy without the need for additional ports for cholecystectomy, while the secondary outcome includes the operative time, amount of intra-operative blood loss, operative or post-operative complications, hospital stay, and portal vein thrombosis Clinical Study Report 12 months Laparoscopic splenectomy, cholecystectomy, pediatric
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