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CTRI Number  CTRI/2024/01/061743 [Registered on: 23/01/2024] Trial Registered Prospectively
Last Modified On: 11/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Global observational study that will allow data collection on the quality of gall bladder surgeries using measures covering infrastructure, care processes and outcomes.  
Scientific Title of Study   Global Evaluation of Cholecystectomy Knowledge and Outcomes  
Trial Acronym  (GEKCO) 
Secondary IDs if Any  
Secondary ID  Identifier 
study Protocol Version 2.0 21/08/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahesh goel 
Designation  Professor and Surgeon  
Affiliation  Tata Memorial Hospital  
Address  Department of surgical oncology 3rd floor room no 328 homibhabha building dr ernest borges marg parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mahesh goel 
Designation  Professor and Surgeon  
Affiliation  Tata Memorial Hospital  
Address  Department of surgical oncology 3rd floor room no 328 homibhabha building dr ernest borges marg parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mahesh goel 
Designation  Professor and Surgeon  
Affiliation  Tata Memorial Hospital  
Address  Department of surgical oncology 3rd floor room no 328 homibhabha building dr ernest borges marg parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820504492  
Fax    
Email  drmaheshgoel@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial hospital Parel Dr Ernest borges Marg parel mumbai maharashtra India 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Department of surgical oncology 3rd floor room no 328 homibhabha building dr ernest borges marg parel mumbai  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Afghanistan
Albania
Algeria
Argentina
Australia
Austria
Azerbaijan
Bahrain
Bangladesh
Belarus
Belgium
Benin
Bhutan
Bolivia
Bosnia and Herzegovina
Botswana
Brazil
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Chile
China
Colombia
Congo
Croatia
Cyprus
Czech Republic
Denmark
Dominica
Ecuador
Egypt
El Salvador
Estonia
Ethiopia
Fiji
Finland
France
Gabon
Gambia
Georgia
Germany
Ghana
Greece
Guatemala
Guinea-Bissau
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran (Islamic Republic of)
Iraq
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Kenya
Kuwait
Latvia
Lebanon
Liberia
Libyan Arab Jamahiriya
Lithuania
Luxembourg
Madagascar
Malaysia
Maldives
Malta
Mexico
Mongolia
Morocco
Mozambique
Namibia
Nepal
Netherlands
New Zealand
Nicaragua
Niger
Nigeria
Norway
Oman
Pakistan
Panama
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Republic of Korea
Romania
Russian Federation
Rwanda
Saudi Arabia
Serbia
Singapore
Slovakia
Slovenia
Somalia
South Africa
Spain
Sri Lanka
Sudan
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tanzania
Thailand
Togo
Trinidad and Tobago
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States of America
Uruguay
Venezuela (Bolivarian Republic of)
Viet Nam  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahesh goel  Tata Memorial Hospital   Department surgical oncology 3rd floor room no 323 homibhabha building dr ernest borges marg parel mumbai
Mumbai
MAHARASHTRA 
09820504492

drmaheshgoel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K829||Disease of gallbladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL   NIL  
Comparator Agent  NIL   NIL  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Age All adult patients (greater than or including 18 years of age).
-Procedure: Primary cholecystectomy, where this is the main procedure planned.

-Approach: Open, laparoscopic (standard and single-port), and robotic. Gasless laparoscopic and robotic approaches are inluded. Laparoscopic and robot converted cases are also eligible.
-Urgency: Elective, delayed and emergency procedures
 
 
ExclusionCriteria 
Details  -Procedure: Patients having a cholecystectomy as a part of another surgical procedure; for example, Whipple’s procedure, bariatric, anti-reflux, or transplant operations, should be excluded.

-Indication: Patients with Mirizzi syndrome should be excluded.

-Return to theatre: Each patient should only be entered into the study once. Any patient returning to theatre and requiring a cholecystectomy for whatever indication, should not be included.

-Known gallbladder malignancy: when the diagnosis of gallbladder cancer is established pre- operatively, the patient should be excluded. However, if gallbladder cancer is found unexpectedly during or after cholecystectomy (i.e. on histology), the patient should be included
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of this study is the compliance to pre-, intra-, and post-operative audit standards   36 months 
 
Secondary Outcome  
Outcome  TimePoints 
-Rates of achieving a critical view of safety.

-Rates of different bailout procedures initiated when safe cholecystectomy is compromised.

-30day and one-year
-Unsuspected gallbladder cancer rates and their 30-day and one-year outcome rates
-A description of the global variation in the availability of cholecystectomy services, training and sustainable practice.
 
36 months 
 
Target Sample Size   Total Sample Size="15000"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cholecystectomy, that is removing the gallbladder, is amongst the most common surgeries performed worldwide. There are mainly three approaches to performing it which are open, laparoscopic, and robotic. Laparoscopic cholecystectomy is currently the preferred for non-cancerous gallbladder disease namely gallstone disease. Since it is amongst the most common procedures, a lot of emphasis is placed on safety and quality assessment.  Safe cholecystectomy is defined as which is safe for both the patient and the operating surgeon. Patient safety includes no injury to the adjoining structures around the gallbladder such as the bile duct and blood vessels.

There is a worldwide lack of evidence regarding the definitions of safety of this surgery. The present study that is Global Evaluation of Cholecystectomy Knowledge, and Outcomes (GECKO) intends to assess these worldwide differences and help to arrive at a common decision. All data on the quality of cholecystectomies will be noted. Patients undergoing open, laparoscopic, and robotic cholecystectomies in routine and emergency settings will be included. Global variation in adhering to the with pre-, intra-, and post-operative standards for cholecystectomy will be assessed along with the assessment of the provision of a safe cholecystectomy. Thus, by undertaking this study we will be assessing whether surgeons all over the world are able to adhere to the quality and safety standards of cholecystectomy.

Patients who give consent to enroll in this study will be receiving the same treatment as those who don’t enroll. There will be no change in treatment or surgical protocol. Only information related to their demographic details, postoperative period in the hospital, and one-year follow-up will be collected.  It is important to understand that clinical care will remain the same irrespective of their enrolment in the study and participating patients will not undergo any extra investigations or procedures. Patients can withdraw their participation at any time they want without giving justification also. There will be no benefits, or compensation provided to participants.

 

 

 

 
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