Health Condition 1: K829- Disease of gallbladder, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the compliance to pre-, intra-, and post-operative audit standardsTimepoint: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -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. Timepoint: 36 months | — |
Countries
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
Contacts
Public ContactMahesh goel
Tata Memorial Hospital
Outcome results
None listed