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

NCT06649578 | Completed

• 1 other identifier: 2022/00303
• Study Type: observational
• Target: 1,016
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery; Cost of Care; Complications

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Total Costs of Bariatric Surgery (USD)

  From completion of surgery till post-operative 90 days

• Time to surgical intervention (hr)

  From completion of surgery till 90 days post-operative

• Number of Participants with Total Parental Nutrition Requirement

  From completion of surgery till post-operative 90 days

• Number of Participants with Blood Transfusion

  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

Study Arms (1)

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

Interventions

Metabolic-bariatric surgery PROCEDURE

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).

Metabolic-Bariatric Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Patients under 18 years old

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (2)

• 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.

  PMID: 19638912 RESULT

• 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.

  PMID: 31592894 RESULT

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Asim Shabbir, MBBS, FRCS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 21, 2024
• Study Start: January 1, 2010
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 23, 2024

Record last verified: 2023-07

Locations

SG (1)