| 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
|
|
|
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
|
|
|
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. |