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.: PACTR202209483039374 Date of Registration: 09/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title acute cholecystitis
Official scientific title comparative study between early and late laparoscopic intervention in cases of acute cholecystitis
Brief summary describing the background and objectives of the trial The majority of digestive tract illnesses are caused by biliary ailments. Cholelithiasis is one of them, and it produces generalized illness, necessitating surgical intervention for complete recovery. Aims: The goal of this study was to compare the outcomes of early (within one week) and delayed (after six weeks) laparoscopic cholecystectomy for acute cholecystitis. This study was done at the General Surgery department, Beni-Suef University hospitals, with 54 cases diagnosed with acute cholecystitis during the study period were included. Patients were randomized using the closed envelope method.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/09/2019
Actual trial start date 15/12/2021
Anticipated date of last follow up 21/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 54
Recruitment status Completed
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group delayed laparoscopic cholecystectomy for acute cholecystitis. one year delayed (after six weeks) laparoscopic cholecystectomy for acute cholecystitis. 54
Control Group early laparoscopic cholecystectomy for acute cholecystitis one year early (within one week) laparoscopic cholecystectomy for acute cholecystitis 54 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with acute cholecystitis were included on Tokyo guidelines 2018, 18 – 80 years old, both genders common bile duct (CBD) stones, previous upper GIT surgeries, immunosuppression, acute pancreatitis, cholangitis, unfitness for laparoscopy, and contraindications for general anesthesia. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Week(s) 60 Week(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 05/01/2020 Helsinki and international conference of harmonization ICH
Ethics Committee Address
Street address City Postal code Country
mohamed hassan beni suef 2711860 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Operative time hours
Secondary Outcome post-operative pain week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
beni suef university hospital mohamed. hassan street bani suef city 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rowida Yehia Elsayed Ali mohamed hassan beni suef 2711860 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor beni suef university hospital mohamed hassan beni suef 2711860 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator wael sakr Wael.Refaat@med.bsu.edu.eg 01142268795 mohamed hassan street
City Postal code Country Position/Affiliation
beni suef 2711860 Egypt prof of surgery
Role Name Email Phone Street address
Public Enquiries ahmed sadat ahmed.elsadat@med.bsu.edu.eg 01134534533 mohamed hassan
City Postal code Country Position/Affiliation
beni suef city 2711860 Egypt dean of faculty
Role Name Email Phone Street address
Scientific Enquiries gamal saed gamalziady2@med.bsu.edu.eg 01234485565 mohamed haasan
City Postal code Country Position/Affiliation
beni suef 2711860 Egypt lecturer of surgery
Role Name Email Phone Street address
Principal Investigator Rowida Ali Rowidayehia88@gmail.com 0122285564 mohamed hassam
City Postal code Country Position/Affiliation
beni suef 2711860 Egypt ass. lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD is available we will share master table for participants. regular within 12 months Statistical Analysis Plan one year cholyctitis
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