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Completed

NCT Number: NCT06649578

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

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.

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Key information

Conditions

Bariatric Surgery Complications Cost of Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Number of Participants with Anastomotic Leak

    Time frame: From completion of surgery till post-operative 90 days

    90 Day Post-Operative Complications

  2. Number of Participants with Bleeding

    Time frame: From completion of surgery till post-operative 90 days

    90 Day Post-Operative Complications

  3. Number of Participants with Perforation

    Time frame: Time Frame: From completion of surgery till post-operative 90 days

    90 Day Post-Operative Complications

  4. Number of Participants with Collection

    Time frame: Time Frame: From completion of surgery till post-operative 90 days

    Collection includes hematoma, pus, serous fluids. Outcome measured to 90 Day Post-Operative.

  5. Number of Participants with Hospital Readmission

    Time frame: From completion of surgery till post-operative 90 days

    Any readmission to hospital from completion of surgery till post-operative 90 days

  6. Number of Participants with Reoperation

    Time frame: 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 outcomes

  1. Total Costs of Bariatric Surgery (USD)

    Time frame: 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.

  2. Time to surgical intervention (hr)

    Time frame: 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

  3. Number of Participants with Total Parental Nutrition Requirement

    Time frame: From completion of surgery till post-operative 90 days

    Use of Total Parental Nutrition during 90 Day Post-Operative

  4. Number of Participants with Blood Transfusion

    Time frame: From completion of surgery till post-operative 90 days

    Any blood transfusion given from completion of surgery till post-operative 90 days

  5. Length of Stay (Days)

    Time frame: From completion of surgery till hospital discharge assessed up to post-operative 90 days

    Length of hospital stay from index operation to hospital discharge

  6. Number of Participants with Emergency Department Attendance

    Time frame: From completion of surgery till post-operative 90 days

    Any Emergency Department Attendance from completion of surgery till post-operative 90 days

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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