ObesityNCT06167005
National Introduction of One Anastomosis Gastric Bypass in the UK National Bariatric Surgery Registry
An observational study of Obesity, run by British Obesity and Metabolic Surgery Society.
Trial summary
This study is investigating a newer surgical procedure called one-anastomosis gastric bypass (OAGB) used for treating obesity within the National Health Service (NHS). We want to understand how well this surgery works and its effects on patients' health. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Primary bariatric-metabolic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 70,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing primary bariatric metabolic surgery within the UK National Bariatric Surgery Registry
Who may be able to join
- All primary bariatric metabolic surgeries performed between January 2009 and December 2019
Who cannot join
- Individuals under 18 years of age, those undergoing revisional surgery (defined as conversion to another bariatric procedure), or gastric balloon insertion as the sole treatment
About this study
This study is investigating a newer surgical procedure called one-anastomosis gastric bypass (OAGB) used for treating obesity within the National Health Service (NHS). We want to understand how well this surgery works and its effects on patients' health. We'll look at data from adults who had this surgery, tracking everything from before the operation to after they go home and comparing to other types of operation for weight loss. We'll check for any problems during or after surgery, how long they stay in the hospital, and how much weight they lose. We're also interested in seeing if other health issues related to obesity get better. By doing this, we hope to learn more about how effective and safe this surgery is and how it's being used in hospitals across the country
Read the detailed description
Recent reporting from the International Federation for Surgery for Obesity (IFSO) Registry report that the three most common metabolic surgery procedures are sleeve gastrectomy (SG), Roux-en-y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB)[1]. Introduced by Rutledge in 1997[2], OAGB is now increasing being used in bariatric practice. Recent network meta-analysis indicates OAGB may offer comparable weight loss whilst minimising complications[3]. Literature published from both the IFSO Registry and the Israeli National Registry indicate increased use of OAGB in the surgical treatment of obesity[1, 4].
The safe introduction of new surgical procedures can be confounded by learning effects for both operative technique and perioperative care practices[5]. No study has yet considered the introduction of OAGB at a population or national registry level.
The aim of the study is to study the introduction of OAGB into NHS practice in the national bariatric surgery registry.
Study population: Adult patients undergoing surgery for obesity using one-anastomosis gastric bypass Exclusions: Paediatric cases
Data All patient undergoing OAGB operations within the NBSR - pre-operative, intra-operative and postoperative data as described below
Outcome measures Perioperative outcomes Complications Return to theatre Length of stay Percentage of OAGB practice as a proportion of total bariatric surgery practice at individual hospitals
Longer term outcomes Total body weight loss Excess weight loss Remission of comorbidities
References
- Welbourn R, Hollyman M, Kinsman R, Dixon J, Cohen R, Morton J, et al. Bariatric-Metabolic Surgery Utilisation in Patients With and Without Diabetes: Data from the IFSO Global Registry 2015-2018. Obes Surg. 2021 Feb 27. PubMed PMID: 33638756. Epub 2021/02/28.
- Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. PubMed PMID: 11433900. Epub 2001/07/04.
- Currie AC, Askari A, Fangueiro A, Mahawar K. Network meta-analysis of metabolic surgery procedures for the treatment of obesity and diabetes. Obes Surg. In Press.
- Kaplan U, Romano-Zelekha O, Goitein D, Keren D, Gralnek IM, Boker LK, et al. Trends in Bariatric Surgery: a 5-Year Analysis of the Israel National Bariatric Surgery Registry. Obes Surg. 2020 May;30(5):1761-7. PubMed PMID: 32008257. Epub 2020/02/03.
- Dimick JB, Sedrakyan A, McCulloch P. The IDEAL Framework for Evaluating Surgical Innovation: How It Can Be Used to Improve the Quality of Evidence. JAMA Surg. 2019 Jun 5. PubMed PMID: 31166583. Epub 2019/06/06.
- Conditions
- Obesity
- Being tested
- Primary bariatric-metabolic surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary bariatric-metabolic surgeryProcedure or surgery
Primary bariatric-metabolic surgery
| Study group | Role | What they receive |
|---|---|---|
| One anastomosis gastric bypass | Not described Receives: Procedure: Primary bariatric-metabolic surgery | |
| Roux en y gastric bypass | Not described Receives: Procedure: Primary bariatric-metabolic surgery | |
| Sleeve gastrectomy | Not described Receives: Procedure: Primary bariatric-metabolic surgery | |
| Adjustable gastric band | Not described Receives: Procedure: Primary bariatric-metabolic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity
Measured: 30 day
Weight loss
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study startJan 2009
- Primary completionDec 2020
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Obesity and Metabolic Surgery Society
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Andrew Currie, British Obesity and Metabolic Surgery Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167005
- Sponsor's protocol ID
- 0001
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Welbourn R, Hollyman M, Kinsman R, Dixon J, Cohen R, Morton J, Ghaferi A, Higa K, Ottosson J, Pattou F, Al-Sabah S, Anvari M, Himpens J, Liem R, Vage V, Walton P, Brown W, Kow L. Bariatric-Metabolic Surgery Utilisation in Patients With and Without Diabetes: Data from the IFSO Global Registry 2015-2018. Obes Surg. 2021 Jun;31(6):2391-2400. doi: 10.1007/s11695-021-05280-6. Epub 2021 Feb 27.
PubMed 33638756Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
PubMed 11433900Currie AC, Askari A, Fangueiro A, Mahawar K. Network Meta-Analysis of Metabolic Surgery Procedures for the Treatment of Obesity and Diabetes. Obes Surg. 2021 Oct;31(10):4528-4541. doi: 10.1007/s11695-021-05643-z. Epub 2021 Aug 7.
PubMed 34363144Kaplan U, Romano-Zelekha O, Goitein D, Keren D, Gralnek IM, Boker LK, Sakran N. Trends in Bariatric Surgery: a 5-Year Analysis of the Israel National Bariatric Surgery Registry. Obes Surg. 2020 May;30(5):1761-1767. doi: 10.1007/s11695-020-04426-2.
PubMed 32008257Dimick JB, Sedrakyan A, McCulloch P. The IDEAL Framework for Evaluating Surgical Innovation: How It Can Be Used to Improve the Quality of Evidence. JAMA Surg. 2019 Aug 1;154(8):685-686. doi: 10.1001/jamasurg.2019.0903. No abstract available.
PubMed 31166583Currie AC, Askari A, Parmar C, Byrne J, Ahmed AR, Pring CM, Khan OA, Small PK, Mahawar K. National introduction of one-anastomosis gastric bypass in the UK National Bariatric Surgery Registry: a cohort study. Int J Surg. 2024 Dec 1;110(12):7404-7413. doi: 10.1097/JS9.0000000000002005.
PubMed 39311895
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Introduction of One Anastomosis Gastric Bypass in the UK National Bariatric Surgery Registry
- ClinicalTrials.gov ID
- NCT06167005
- Acronym / sponsor ID
- 0001
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- British Obesity and Metabolic Surgery SocietyOther government
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 12 Dec 2023 (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.
This study is investigating a newer surgical procedure called one-anastomosis gastric bypass (OAGB) used for treating obesity within the National Health Service (NHS). We want to understand how well this surgery works and its effects on patients' health. We'll look at data from adults who had this surgery, tracking everything from before the operation to after they go home and comparing to other types of operation for weight loss. We'll check for any problems during or after surgery, how long they stay in the hospital, and how much weight they lose. We're also interested in seeing if other health issues related to obesity get better. By doing this, we hope to learn more about how effective and safe this surgery is and how it's being used in hospitals across the country
Detailed description
Recent reporting from the International Federation for Surgery for Obesity (IFSO) Registry report that the three most common metabolic surgery procedures are sleeve gastrectomy (SG), Roux-en-y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB)[1]. Introduced by Rutledge in 1997[2], OAGB is now increasing being used in bariatric practice. Recent network meta-analysis indicates OAGB may offer comparable weight loss whilst minimising complications[3]. Literature published from both the IFSO Registry and the Israeli National Registry indicate increased use of OAGB in the surgical treatment of obesity[1, 4].
The safe introduction of new surgical procedures can be confounded by learning effects for both operative technique and perioperative care practices[5]. No study has yet considered the introduction of OAGB at a population or national registry level.
The aim of the study is to study the introduction of OAGB into NHS practice in the national bariatric surgery registry.
Study population: Adult patients undergoing surgery for obesity using one-anastomosis gastric bypass Exclusions: Paediatric cases
Data All patient undergoing OAGB operations within the NBSR - pre-operative, intra-operative and postoperative data as described below
Outcome measures Perioperative outcomes Complications Return to theatre Length of stay Percentage of OAGB practice as a proportion of total bariatric surgery practice at individual hospitals
Longer term outcomes Total body weight loss Excess weight loss Remission of comorbidities
References
- Welbourn R, Hollyman M, Kinsman R, Dixon J, Cohen R, Morton J, et al. Bariatric-Metabolic Surgery Utilisation in Patients With and Without Diabetes: Data from the IFSO Global Registry 2015-2018. Obes Surg. 2021 Feb 27. PubMed PMID: 33638756. Epub 2021/02/28.
- Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. PubMed PMID: 11433900. Epub 2001/07/04.
- Currie AC, Askari A, Fangueiro A, Mahawar K. Network meta-analysis of metabolic surgery procedures for the treatment of obesity and diabetes. Obes Surg. In Press.
- Kaplan U, Romano-Zelekha O, Goitein D, Keren D, Gralnek IM, Boker LK, et al. Trends in Bariatric Surgery: a 5-Year Analysis of the Israel National Bariatric Surgery Registry. Obes Surg. 2020 May;30(5):1761-7. PubMed PMID: 32008257. Epub 2020/02/03.
- Dimick JB, Sedrakyan A, McCulloch P. The IDEAL Framework for Evaluating Surgical Innovation: How It Can Be Used to Improve the Quality of Evidence. JAMA Surg. 2019 Jun 5. PubMed PMID: 31166583. Epub 2019/06/06.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One anastomosis gastric bypass | – | Procedure: Primary bariatric-metabolic surgery |
| Roux en y gastric bypass | – | Procedure: Primary bariatric-metabolic surgery |
| Sleeve gastrectomy | – | Procedure: Primary bariatric-metabolic surgery |
| Adjustable gastric band | – | Procedure: Primary bariatric-metabolic surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing primary bariatric metabolic surgery within the UK National Bariatric Surgery Registry
Key inclusion criteria (1 listed)
- All primary bariatric metabolic surgeries performed between January 2009 and December 2019
Key exclusion criteria (1 listed)
- Individuals under 18 years of age, those undergoing revisional surgery (defined as conversion to another bariatric procedure), or gastric balloon insertion as the sole treatment
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 |
|---|---|---|
| Primary bariatric-metabolic surgeryPrimary bariatric-metabolic surgery | Procedure or surgery | Adjustable gastric band, One anastomosis gastric bypass, Roux en y gastric bypass, Sleeve gastrectomy |
Primary outcome
Postoperative morbidity
Time frame: 30 day
Weight loss
Time frame: 12 month
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 12 Dec 2023.
- Background: PubMed 33638756Welbourn R, Hollyman M, Kinsman R, Dixon J, Cohen R, Morton J, Ghaferi A, Higa K, Ottosson J, Pattou F, Al-Sabah S, Anvari M, Himpens J, Liem R, Vage V, Walton P, Brown W, Kow L. Bariatric-Metabolic Surgery Utilisation in Patients With and Without Diabetes: Data from the IFSO Global Registry 2015-2018. Obes Surg. 2021 Jun;31(6):2391-2400. doi: 10.1007/s11695-021-05280-6. Epub 2021 Feb 27.
- Background: PubMed 11433900Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
- Background: PubMed 34363144Currie AC, Askari A, Fangueiro A, Mahawar K. Network Meta-Analysis of Metabolic Surgery Procedures for the Treatment of Obesity and Diabetes. Obes Surg. 2021 Oct;31(10):4528-4541. doi: 10.1007/s11695-021-05643-z. Epub 2021 Aug 7.
- Background: PubMed 32008257Kaplan U, Romano-Zelekha O, Goitein D, Keren D, Gralnek IM, Boker LK, Sakran N. Trends in Bariatric Surgery: a 5-Year Analysis of the Israel National Bariatric Surgery Registry. Obes Surg. 2020 May;30(5):1761-1767. doi: 10.1007/s11695-020-04426-2.
- Background: PubMed 31166583Dimick JB, Sedrakyan A, McCulloch P. The IDEAL Framework for Evaluating Surgical Innovation: How It Can Be Used to Improve the Quality of Evidence. JAMA Surg. 2019 Aug 1;154(8):685-686. doi: 10.1001/jamasurg.2019.0903. No abstract available.
- Derived from this study: PubMed 39311895Currie AC, Askari A, Parmar C, Byrne J, Ahmed AR, Pring CM, Khan OA, Small PK, Mahawar K. National introduction of one-anastomosis gastric bypass in the UK National Bariatric Surgery Registry: a cohort study. Int J Surg. 2024 Dec 1;110(12):7404-7413. doi: 10.1097/JS9.0000000000002005.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by British Obesity and Metabolic Surgery Society.
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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative morbidity (time frame: 30 day). The study lists 2 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 NCT06167005, which also lists 6 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 12 Dec 2023.