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

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.

Study Overview

• Status: Completed
• Conditions: Complications; Bariatric Surgery; Cost of Care
• Intervention / Treatment: Procedure: Metabolic-bariatric surgery

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.

• Study Type: Observational
• Enrollment (Actual): 1016

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our patients are consecutive patients that underwent metabolic-bariatric surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metabolic-Bariatric Surgery; Patients undergoing Metabolic-Bariatric Surgery are divided into either Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB) or One-Anastomosis Gastric Bypass (OAGB).	Procedure: Metabolic-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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Anastomotic Leak	90 Day Post-Operative Complications	From completion of surgery till post-operative 90 days
Number of Participants with Bleeding	90 Day Post-Operative Complications	From completion of surgery till post-operative 90 days
Number of Participants with Perforation	90 Day Post-Operative Complications	Time Frame: From completion of surgery till post-operative 90 days
Number of Participants with Collection	Collection includes hematoma, pus, serous fluids. Outcome measured to 90 Day Post-Operative.	Time Frame: From completion of surgery till post-operative 90 days
Number of Participants with Hospital Readmission	Any readmission to hospital from completion of surgery till post-operative 90 days	From completion of surgery till post-operative 90 days
Number of Participants with Reoperation	Any reoperation due to any complications from completion of surgery till post-operative 90 days	From completion of surgery till post-operative 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Costs of Bariatric Surgery (USD)	Total costs of all events that occur from surgery till post-operative 90 days will be included. Costs will be extracted from hospital records.	From completion of surgery till post-operative 90 days
Time to surgical intervention (hr)	Time to surgical intervention for patients requiring surgical treatment for post-operative complications. Time will be extracted from surgical records	From completion of surgery till 90 days post-operative
Number of Participants with Total Parental Nutrition Requirement	Use of Total Parental Nutrition during 90 Day Post-Operative	From completion of surgery till post-operative 90 days
Number of Participants with Blood Transfusion	Any blood transfusion given from completion of surgery till post-operative 90 days	From completion of surgery till post-operative 90 days
Length of Stay (Days)	Length of hospital stay from index operation to hospital discharge	From completion of surgery till hospital discharge assessed up to post-operative 90 days
Number of Participants with Emergency Department Attendance	Any Emergency Department Attendance from completion of surgery till post-operative 90 days	From completion of surgery till post-operative 90 days

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: National Medical Research Council (NMRC), Singapore
• Investigators: Principal Investigator: Asim Shabbir, MBBS, FRCS, National University Hospital, Singapore

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Outcomes; Costs; Asians; Comprehensive Complication Index; Metabolic-bariatric surgery
• Other Study ID Numbers: 2022/00303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared upon reasonable request towards corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No