Clinical trial NCT06649578: Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks
Official title: Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks: Insights From a Decade-Long Cohort Study of 1016 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Cost of Care
Complications
Keywords: Metabolic-bariatric surgery
Costs
Outcomes
Comprehensive Complication Index
Asians
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2024-10-21
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our patients are consecutive patients that underwent metabolic-bariatric surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Anastomotic Leak
timeFrame: From completion of surgery till post-operative 90 days
measure: Number of Participants with Bleeding
timeFrame: From completion of surgery till post-operative 90 days
measure: Number of Participants with Perforation
timeFrame: Time Frame: From completion of surgery till post-operative 90 days
measure: Number of Participants with Collection
timeFrame: Time Frame: From completion of surgery till post-operative 90 days
measure: Number of Participants with Hospital Readmission
timeFrame: From completion of surgery till post-operative 90 days
measure: Number of Participants with Reoperation
timeFrame: From completion of surgery till post-operative 90 days
Secondary outcomes:
measure: Total Costs of Bariatric Surgery (USD)
timeFrame: From completion of surgery till post-operative 90 days
measure: Time to surgical intervention (hr)
timeFrame: From completion of surgery till 90 days post-operative
measure: Number of Participants with Total Parental Nutrition Requirement
timeFrame: From completion of surgery till post-operative 90 days
measure: Number of Participants with Blood Transfusion
timeFrame: From completion of surgery till post-operative 90 days
measure: Length of Stay (Days)
timeFrame: From completion of surgery till hospital discharge assessed up to post-operative 90 days
measure: Number of Participants with Emergency Department Attendance
timeFrame: From completion of surgery till post-operative 90 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Asim Shabbir, MBBS, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
citation: Gero D, Raptis DA, Vleeschouwers W, van Veldhuisen SL, Martin AS, Xiao Y, Galvao M, Giorgi M, Benois M, Espinoza F, Hollyman M, Lloyd A, Hosa H, Schmidt H, Garcia-Galocha JL, van de Vrande S, Chiappetta S, Menzo EL, Aboud CM, Luthy SG, Orchard P, Rothe S, Prager G, Pournaras DJ, Cohen R, Rosenthal R, Weiner R, Himpens J, Torres A, Higa K, Welbourn R, Berry M, Boza C, Iannelli A, Vithiananthan S, Ramos A, Olbers T, Sepulveda M, Hazebroek EJ, Dillemans B, Staiger RD, Puhan MA, Peterli R, Bueter M. Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy. Ann Surg. 2019 Nov;270(5):859-867. doi: 10.1097/SLA.0000000000003512.