Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201605001619292 Date of Approval: 06/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laparoscopic cholecystectomy with retroinfundibular approach in difficult cases
Official scientific title Laparoscopic cholecystectomy with retroinfundibular approach VS. standard laparoscopic cholecystectomy in difficult cases with high risk of biliary injury.
Brief summary describing the background and objectives of the trial Laparoscopic cholecystectomy (LC) becomes the standard surgical procedure for treating gallstones. The standard safe LC requires proper dissection of Calot¿s triangle with its content to achieve the critical view of safety. This may be difficult in the presence of acute or long standing chronic inflammation, dense adhesions resulting in higher incidence of bile duct injury and conversion to open. This study aimed to evaluate safety and efficacy of near total laparoscopic cholecystectomy (NTLC) by retro-infundibular approach when Calt's traiangle was scarred and unsafe to be dissected in comparison to standard laparoscopic cholecystectomy (SLC)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Digestive System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 16/11/2014
Actual trial start date 12/01/2014
Anticipated date of last follow up 10/01/2016
Actual Last follow-up date 10/01/2016
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 125
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
Parallel: different groups receive different interventions at same time during study Randomised computer based Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Shift up in Dissection to Retroinfundipular area with Near Total Laparoscopic Cholecystectomy (NTLC) Shift up in Dissection to Retroinfundipular area with Near Total Laparoscopic Cholecystectomy (NTLC) 65
Control Group standard laparoscopic cholecystectomy standard laparoscopic cholecystectomy 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all patients found to have scarred Calt's triangle during laparocopic cholecystectomy patient unfit for surgery, cirrhotic patient and patient who had adhesion made the dissection difficult but Calt's wasn't scarred 20 Year(s) 75 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 18/12/2014 Minia university- Faculty of medicine ¿ Department of surgery ¿ Research Ethical committee
Ethics Committee Address
Street address City Postal code Country
kornesh elnel minia 61511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of biliary injury the 1st week posoperative
Secondary Outcome conversion rate ,operative time and length of hospital stay the 1st 6 weeks posoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia university hospital kornesh Elnel , Department of surgery, Minia university hospital, Egypt. Minia 61511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
minia university hospital kornesh Elnel , Department of surgery, Minia university hospital, Egypt. Minia 61511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor minia university hospital kornesh Elnel , Department of surgery, Minia university hospital, Egypt. Minia 61511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Aymen Mohammed Hassnen kornesh Elnel , Department of surgery, Minia university hospital, Egypt. Minia 61511 Egypt
Amr Gaafar kornesh Elnel , Department of surgery, Minia university hospital, Egypt. Minia 61511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Moustafa Sewefy sewafy@yahoo.co.uk +201006448805 kornesh Elnel, Minia university hospital
City Postal code Country Position/Affiliation
Minia 61511 Egypt MD, Lecturer, consult gen surgery, Depart surgery, Minia univ hosp, Egypt
Role Name Email Phone Street address
Public Enquiries Aymen Hassanen hassanena@gmail.com +01092758555 kornesh Elnel, Minia university hospital
City Postal code Country Position/Affiliation
Minia 61511 Egypt MD, Prof consult gen surgery, Dept Surgery, Minia Univ Hosp
Role Name Email Phone Street address
Scientific Enquiries Amr Gafaar mazenzona183@yahoo.com +01002087049 kornesh Elnel, Minia university hospital
City Postal code Country Position/Affiliation
Minia 61511 Egypt MD, Assist Lecturer, consult gen surgery, Dept of Surg, Minia Univ hosp
REPORTING
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