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.: PACTR201701001918837 Date of Approval: 13/12/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early Versus Delayed Laparoscopic Cholecystectomy for Complicated Acute Calculous Cholecystitis: A Prospective Randomized Study
Official scientific title Early Versus Delayed Laparoscopic Cholecystectomy for Complicated Acute Calculous Cholecystitis
Brief summary describing the background and objectives of the trial Acute cholecystitis is the major complication of biliary lithiasis, for which laparoscopic treatment has been established as the standard therapy. The question addressed was whether early laparoscopic cholecystectomy in patients with complicated acute cholecystitis provides better post-operative outcomes than a delayed laparoscopic cholecystectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied complicated acute cholecystitis,Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/11/2016
Actual trial start date 01/11/2016
Anticipated date of last follow up 15/12/2016
Actual Last follow-up date 01/12/2016
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
Recruitment status Closed to recruitment,follow-up continuing
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 randomisation using computer software program sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group late laparoscopic cholecystectomy for complicated acute cholecystitis duration study 1 year laparoscopic intervention 75 Active-Treatment of Control Group
Experimental Group early laparoscopic cholecystectomy for complicated acute cholecystitis duration study 1 year laparoscopic intervention 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients having clinical or radiological evidence of ACC were included, defined according to the 2007 Tokyo Guidelines assessment (TG07) for diagnostic criteria and severity assessment criteria for acute cholecystitis; grade I to III) 1. Non-complicated ACC. 2. Acute pancreatitis secondary to ACC. 3. ACC associated with choledocholithiasis. 4. Decompensated liver cirrhosis. 5. Acalculous cholecystitis. 6. Mental disease preventing informed consent. 7. ACC diagnosed after one week from the onset of attack. 20 Year(s) 70 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 01/10/2016 local ethics comittee of the Faculty of Medicine, Alexandria University, Egypt
Ethics Committee Address
Street address City Postal code Country
Shamblion St. Raml Station, Alexandria, Egypt Alexandria 55555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome primary endpoint The primary outcome is the endpoint of any major intraoperative or postoperative complications, duration of surgery, difficulty of procedures, conversion rates, and mortality during the follow-up period.
Secondary Outcome secondary endpoint Secondary outcome include all other complications, pain assessment, and duration of hospital admission.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Emergency and Gastrointestinal Surgery Unit, Alexandria Main University Hospital, the Faculty of Medicine, Alexandria University.Egypt Shamblion St. Raml Station, Alexandria, Egypt Alexandria 55555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine, alexandria university, egypt Shamblion St. Raml Station, Alexandria, Egypt Alexandria 55555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor dr.mohamed kassem Shamblion St. Raml Station, Alexandria, Egypt Alexandria 55555 Egypt Funding Agency
Primary Sponsor faculty of medicine, alexandria university, egypt Shamblion St. Raml Station, Alexandria, Egypt Alexandria 55555 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr.mohamed kassem Shamblion St. Raml Station, Alexandria, Egypt Alexandria 55555 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed kassem dr_m_kassem@yahoo.com 00201001224750 Shaarawy St, loran,
City Postal code Country Position/Affiliation
alexandria 4765 Egypt A.professor of GIT surgery, faculty of medicine, alexandria university, Egypt
Role Name Email Phone Street address
Public Enquiries hany elhaddad drhanyelhaddad@yahoo.com 00201001989231 SidiGaber
City Postal code Country Position/Affiliation
alexandria 4563 Egypt A.professor of GIT surgery, faculty of medicine, alexandria university, Egypt
Role Name Email Phone Street address
Scientific Enquiries mohamed mourad forest2112@hotmail.com 002035886171 Smouha
City Postal code Country Position/Affiliation
alexandria 3764 Egypt lecturer of GIT surgery, faculty of medicine, alexandria university, Egypt
REPORTING
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