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

October 20, 2024 updated by: National University Hospital, Singapore

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1016

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Anastomotic Leak
Time Frame: From completion of surgery till post-operative 90 days
90 Day Post-Operative Complications
From completion of surgery till post-operative 90 days
Number of Participants with Bleeding
Time Frame: From completion of surgery till post-operative 90 days
90 Day Post-Operative Complications
From completion of surgery till post-operative 90 days
Number of Participants with Perforation
Time Frame: Time Frame: From completion of surgery till post-operative 90 days
90 Day Post-Operative Complications
Time Frame: From completion of surgery till post-operative 90 days
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.
Time Frame: From completion of surgery till post-operative 90 days
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
From completion of surgery till post-operative 90 days
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
From completion of surgery till post-operative 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From completion of surgery till post-operative 90 days
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
From completion of surgery till 90 days post-operative
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
From completion of surgery till post-operative 90 days
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
From completion of surgery till post-operative 90 days
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
From completion of surgery till hospital discharge assessed up to post-operative 90 days
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
From completion of surgery till post-operative 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Medical Research Council (NMRC), Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asim Shabbir, MBBS, FRCS, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings