Bariatric SurgeryNCT06649578
Comparing Bariatric Surgery Outcomes in Predominantly High-Risk Asian Patients to Global Benchmarks
An observational study of Bariatric Surgery and Cost of Care, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Cost of Care, Complications
- What is being tested?
- Metabolic-bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,016 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2010to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our patients are consecutive patients that underwent metabolic-bariatric surgery.
Who may be able to join
- 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).
Who cannot join
- Patients under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bariatric Surgery, Cost of Care, Complications
- Being tested
- Metabolic-bariatric surgery
- Keywords
- Metabolic-bariatric surgery, Costs, Outcomes, Comprehensive Complication Index, Asians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic-bariatric surgeryProcedure or 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Metabolic-bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Anastomotic Leak
90 Day Post-Operative Complications
Measured: From completion of surgery till post-operative 90 days
Number of Participants with Bleeding
90 Day Post-Operative Complications
Measured: From completion of surgery till post-operative 90 days
Number of Participants with Perforation
90 Day Post-Operative Complications
Measured: 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.
Measured: 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
Measured: 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
Measured: From completion of surgery till post-operative 90 days
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: From completion of surgery till post-operative 90 days
Length of Stay (Days)
Length of hospital stay from index operation to hospital discharge
Measured: 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
Measured: From completion of surgery till post-operative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jan 2010
- Primary completion1 Feb 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Asim Shabbir, MBBS, FRCS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649578
- Sponsor's protocol ID
- 2022/00303
- Status last verified
- Jul 2023
- First submitted
- 8 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request towards corresponding author.
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.
PubMed 19638912Gero 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.
PubMed 31592894
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06649578
- Acronym / sponsor ID
- 2022/00303
- Conditions
- Bariatric Surgery, Cost of Care, Complications
- Keywords
- Metabolic-bariatric surgery, Costs, Outcomes, Comprehensive Complication Index, Asians
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metabolic-Bariatric Surgery | – | Procedure: Metabolic-bariatric surgeryPatients undergoing Metabolic-Bariatric Surgery are divided into either Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB) or One-Anastomosis Gastric Bypass (OAGB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our patients are consecutive patients that underwent metabolic-bariatric surgery.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic-bariatric surgeryOur 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). | Procedure or surgery | Metabolic-Bariatric Surgery |
Primary outcome
Number of Participants with Anastomotic Leak
Time frame: From completion of surgery till post-operative 90 days
90 Day Post-Operative Complications
Number of Participants with Bleeding
Time frame: From completion of surgery till post-operative 90 days
90 Day Post-Operative Complications
Number of Participants with Perforation
Time frame: Time Frame: From completion of surgery till post-operative 90 days
90 Day Post-Operative Complications
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.
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
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
6 secondary outcomes
Total Costs of Bariatric Surgery (USD)
Time frame: 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
Number of Participants with Total Parental Nutrition Requirement
Time frame: 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
Length of Stay (Days)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Results publication: PubMed 19638912Clavien 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.
- Results publication: PubMed 31592894Gero 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.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request towards corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asim Shabbir, MBBS, FRCS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Cost of Care, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Anastomotic Leak (time frame: From completion of surgery till post-operative 90 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06649578, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.