Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks
- Conditions
- Bariatric SurgeryCost of CareComplications
- Registration Number
- NCT06649578
- Lead Sponsor
- National University Hospital, Singapore
- Brief Summary
While metabolic-bariatric surgery is a safe and well-established surgery, complications do occur and can have significant impact on the patient. With the study, the investigators aim to establish the proportion of patients that will have complications and understand what the impact of complications are on costs.
- Detailed Description
Complications after metabolic-bariatric surgery can be catastrophic and have significant impact on costs, morbidity, and mortality. As current global benchmarks for complications rates in MBS are based on standard risk patients in western populations, the benchmark complication rates in high-risk patients and Asian populations are unknown. The investigators aim to evaluate the incidence of complications in 1016 consecutive patients and the impact of complications on costs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1016
- The inclusion criteria were patients who underwent either primary or revisional MBS comprising Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB) or One-Anastomosis Gastric Bypass (OAGB).
- Patients under 18 years old
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Anastomotic Leak From completion of surgery till post-operative 90 days 90 Day Post-Operative Complications
Number of Participants with Bleeding From completion of surgery till post-operative 90 days 90 Day Post-Operative Complications
Number of Participants with Perforation Time Frame: From completion of surgery till post-operative 90 days 90 Day Post-Operative Complications
Number of Participants with Collection Time Frame: From completion of surgery till post-operative 90 days Collection includes hematoma, pus, serous fluids. Outcome measured to 90 Day Post-Operative.
Number of Participants with Hospital Readmission From completion of surgery till post-operative 90 days Any readmission to hospital from completion of surgery till post-operative 90 days
Number of Participants with Reoperation From completion of surgery till post-operative 90 days Any reoperation due to any complications from completion of surgery till post-operative 90 days
- Secondary Outcome Measures
Name Time Method Total Costs of Bariatric Surgery (USD) From completion of surgery till post-operative 90 days Total costs of all events that occur from surgery till post-operative 90 days will be included. Costs will be extracted from hospital records.
Time to surgical intervention (hr) From completion of surgery till 90 days post-operative Time to surgical intervention for patients requiring surgical treatment for post-operative complications. Time will be extracted from surgical records
Number of Participants with Total Parental Nutrition Requirement From completion of surgery till post-operative 90 days Use of Total Parental Nutrition during 90 Day Post-Operative
Number of Participants with Blood Transfusion From completion of surgery till post-operative 90 days Any blood transfusion given from completion of surgery till post-operative 90 days
Length of Stay (Days) From completion of surgery till hospital discharge assessed up to post-operative 90 days Length of hospital stay from index operation to hospital discharge
Number of Participants with Emergency Department Attendance From completion of surgery till post-operative 90 days Any Emergency Department Attendance from completion of surgery till post-operative 90 days
Trial Locations
- Locations (1)
National University Hospital
🇸🇬Singapore, Singapore