National Introduction of One Anastomosis Gastric Bypass in the UK National Bariatric Surgery Registry

NCT06167005 | Completed

• 1 other identifier: 0001
• Study Type: observational
• Target: 70,000
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Postoperative morbidity

  30 day

• Weight loss

  12 month

Study Arms (4)

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

Interventions

Primary bariatric-metabolic surgery PROCEDURE

Primary bariatric-metabolic surgery

Adjustable gastric band; One anastomosis gastric bypass; Roux en y gastric bypass; Sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing primary bariatric metabolic surgery within the UK National Bariatric Surgery Registry

You may qualify if:

• All primary bariatric metabolic surgeries performed between January 2009 and December 2019

You may not qualify if:

• 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

Sponsors & Collaborators

• British Obesity and Metabolic Surgery Society: lead

Related Publications (6)

• 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.

  PMID: 33638756 BACKGROUND

• Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.

  PMID: 11433900 BACKGROUND

• Currie 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.

  PMID: 34363144 BACKGROUND

• Kaplan 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.

  PMID: 32008257 BACKGROUND

• 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 Aug 1;154(8):685-686. doi: 10.1001/jamasurg.2019.0903. No abstract available.

  PMID: 31166583 BACKGROUND

• Currie 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.

  PMID: 39311895 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrew Currie

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: January 1, 2009
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share