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Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks

Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks: Insights From a Decade-Long Cohort Study of 1016 Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06649578
Enrollment
1016
Registered
2024-10-21
Start date
2010-01-01
Completion date
2023-04-01
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Complications, Cost of Care

Keywords

Metabolic-bariatric surgery, Costs, Outcomes, Comprehensive Complication Index, Asians

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.

Interventions

PROCEDUREMetabolic-bariatric surgery

Our study is conducted in a predominantly high-risk Asian population that will be undergoing metabolic-bariatric surgery. The types of surgery can be divided into Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB) or One-Anastomosis Gastric Bypass (OAGB).

Sponsors

National Medical Research Council (NMRC), Singapore
CollaboratorOTHER_GOV
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* Patients under 18 years old

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with ReoperationFrom completion of surgery till post-operative 90 daysAny reoperation due to any complications from completion of surgery till post-operative 90 days
Number of Participants with Anastomotic LeakFrom completion of surgery till post-operative 90 days90 Day Post-Operative Complications
Number of Participants with BleedingFrom completion of surgery till post-operative 90 days90 Day Post-Operative Complications
Number of Participants with PerforationTime Frame: From completion of surgery till post-operative 90 days90 Day Post-Operative Complications
Number of Participants with CollectionTime Frame: From completion of surgery till post-operative 90 daysCollection includes hematoma, pus, serous fluids. Outcome measured to 90 Day Post-Operative.
Number of Participants with Hospital ReadmissionFrom completion of surgery till post-operative 90 daysAny readmission to hospital from completion of surgery till post-operative 90 days

Secondary

MeasureTime frameDescription
Number of Participants with Total Parental Nutrition RequirementFrom completion of surgery till post-operative 90 daysUse of Total Parental Nutrition during 90 Day Post-Operative
Number of Participants with Blood TransfusionFrom completion of surgery till post-operative 90 daysAny blood transfusion given from completion of surgery till post-operative 90 days
Total Costs of Bariatric Surgery (USD)From completion of surgery till post-operative 90 daysTotal 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-operativeTime to surgical intervention for patients requiring surgical treatment for post-operative complications. Time will be extracted from surgical records
Length of Stay (Days)From completion of surgery till hospital discharge assessed up to post-operative 90 daysLength of hospital stay from index operation to hospital discharge
Number of Participants with Emergency Department AttendanceFrom completion of surgery till post-operative 90 daysAny Emergency Department Attendance from completion of surgery till post-operative 90 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026