NCT06829381

Brief Summary

One Anastomosis Gastric Bypass (OAGB) is the most common metabolic and bariatric surgery (MBS) in Israel, recognized for its effectiveness in achieving sustainable weight loss and mitigating obesity-related diseases. The metabolic outcomes of OAGB are significantly influenced by the length of the biliopancreatic limb (BPL). The objective of this study is to determine whether tailoring the BPL length to the total small bowel length (TSBL) results in more effective weight loss compared to patients undergoing OAGB with a fixed BPL of 180 cm. Efficacy and safety of this approach will also be evaluated, ensuring it does not lead to long-term morbidity or negatively impact patients' quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2025Jan 2029

Study Start

First participant enrolled

January 29, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

February 11, 2025

Last Update Submit

July 21, 2025

Conditions

Metabolic and Bariatric Surgery

Keywords

one anastomosis gastric bypassobesityweight losstailoring

Outcome Measures

Primary Outcomes (1)

  • weight loss

    Total weight loss will be calculated as - preoperative weight-last follow-up weight/preoperative weight \* 100

    6 months, one year, and 3 years after surgery

Secondary Outcomes (4)

  • Postoperative nutritional complications

    6 months and one year after surgery

  • resolution of obesity related diseases

    6 months and one year postopertively

  • Bariatric Analysis and Reporting Outcome System score

    6 months and one year postopertively

  • Fecal Score

    6 months, 1 year and 3 years

Study Arms (2)

Control group BPL 180 cm

ACTIVE COMPARATOR

Total bowel length measure and BPL will be 180 cm regardless of total small bowel length

Procedure: Control - BPL 180 cm

Tailored BPL length

EXPERIMENTAL

Total bowel length measure and BPL will be 40% of total bowel length ensuring at least 250 cm common channel

Procedure: Tailored BPL length

Interventions

Tailored BPL lengthPROCEDURE

Total bowel length measure and BPL will be 40% of total bowel length ensuring at least 250 cm common channel

Tailored BPL length
Control - BPL 180 cmPROCEDURE

Total bowel length measure and BPL will be180 cm

Control group BPL 180 cm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years) undergoing OAGB

You may not qualify if:

  • Patients \<18 years, pregnant women, or those lacking decision-making capacity Prior bariatric surgery Short bowel (\<450 cm)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (21)

  • Slagter N, de Heide LJM, Jutte EH, Kaijser MA, Damen SL, van Beek AP, Emous M. Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial. Trials. 2022 Jun 22;23(1):526. doi: 10.1186/s13063-022-06456-w.

    PMID: 35733198BACKGROUND

  • Hany M, Zidan A, Aboelsoud MR, Torensma B. Laparoscopic sleeve gastrectomy vs one-anastomosis gastric bypass 5-year follow-up: a single-blinded randomized controlled trial. J Gastrointest Surg. 2024 May;28(5):621-633. doi: 10.1016/j.gassur.2024.01.038. Epub 2024 Feb 9.

    PMID: 38704199BACKGROUND

  • Kansou G, Lechaux D, Delarue J, Badic B, Le Gall M, Guillerm S, Bail JP, Thereaux J. Laparoscopic sleeve gastrectomy versus laparoscopic mini gastric bypass: One year outcomes. Int J Surg. 2016 Sep;33 Pt A:18-22. doi: 10.1016/j.ijsu.2016.07.051. Epub 2016 Jul 22.

    PMID: 27452299BACKGROUND

  • Jones NR, McCormack T, Constanti M, McManus RJ. Diagnosis and management of hypertension in adults: NICE guideline update 2019. Br J Gen Pract. 2020 Jan 30;70(691):90-91. doi: 10.3399/bjgp20X708053. Print 2020 Feb. No abstract available.

    PMID: 32001477BACKGROUND

  • Riddle MC, Cefalu WT, Evans PH, Gerstein HC, Nauck MA, Oh WK, Rothberg AE, le Roux CW, Rubino F, Schauer P, Taylor R, Twenefour D. Consensus Report: Definition and Interpretation of Remission in Type 2 Diabetes. Diabetes Care. 2021 Aug 30;44(10):2438-44. doi: 10.2337/dci21-0034. Online ahead of print.

    PMID: 34462270BACKGROUND

  • Schijns W, Aarts EO, Berends FJ, Janssen IM, Schweitzer DH. Loose and frequent stools and PTH levels are positively correlated post-gastric bypass surgery due to less efficient intestinal calcium absorption. Surg Obes Relat Dis. 2016 Sep-Oct;12(8):1548-1553. doi: 10.1016/j.soard.2016.04.011. Epub 2016 Apr 13.

    PMID: 27396549BACKGROUND

  • Oria HE, Moorehead MK. Updated Bariatric Analysis and Reporting Outcome System (BAROS). Surg Obes Relat Dis. 2009 Jan-Feb;5(1):60-6. doi: 10.1016/j.soard.2008.10.004. Epub 2008 Nov 1.

    PMID: 19161935BACKGROUND

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542BACKGROUND

  • Abu-Abeid A, Vitiello A, Berardi G, Dayan D, Velotti N, Schiavone V, Franzese A, Musella M. Implementation of updated enhanced recovery after bariatric surgery guidelines: adapted protocol in a single tertiary center. Updates Surg. 2024 Aug;76(4):1397-1404. doi: 10.1007/s13304-024-01824-4. Epub 2024 Mar 28.

    PMID: 38546967BACKGROUND

  • Felsenreich DM, Langer FB, Eichelter J, Jedamzik J, Gensthaler L, Nixdorf L, Gachabayov M, Rojas A, Vock N, Zach ML, Prager G. Bariatric Surgery-How Much Malabsorption Do We Need?-A Review of Various Limb Lengths in Different Gastric Bypass Procedures. J Clin Med. 2021 Feb 10;10(4):674. doi: 10.3390/jcm10040674.

    PMID: 33578635BACKGROUND

  • Butler AA, O'Rourke RW. Bariatric surgery in the era of personalized medicine. Gastroenterology. 2013 Mar;144(3):497-500. doi: 10.1053/j.gastro.2013.01.027. Epub 2013 Jan 21. No abstract available.

    PMID: 23347671BACKGROUND

  • Thanos PK, Hanna C, Mihalkovic A, Hoffman AB, Posner AR, Busch J, Smith C, Badgaiyan RD, Blum K, Baron D, Mastrandrea LD, Quattrin T. The First Exploratory Personalized Medicine Approach to Improve Bariatric Surgery Outcomes Utilizing Psychosocial and Genetic Risk Assessments: Encouraging Clinical Research. J Pers Med. 2023 Jul 20;13(7):1164. doi: 10.3390/jpm13071164.

    PMID: 37511777BACKGROUND

  • Soong TC, Almalki OM, Lee WJ, Ser KH, Chen JC, Wu CC, Chen SC. Measuring the small bowel length may decrease the incidence of malnutrition after laparoscopic one-anastomosis gastric bypass with tailored bypass limb. Surg Obes Relat Dis. 2019 Oct;15(10):1712-1718. doi: 10.1016/j.soard.2019.08.010. Epub 2019 Aug 21.

    PMID: 31558409BACKGROUND

  • Abu-Abeid A, Bendayan A, Yuval JB, Eldar SM, Lahat G, Lessing Y. Primary versus Revisional One Anastomosis Gastric Bypass: Outcomes of Patients with at Least 8-Year Follow-Up. Obes Facts. 2024;17(3):303-310. doi: 10.1159/000538768. Epub 2024 Apr 9.

    PMID: 38593760BACKGROUND

  • Shahmiri SS, Pazouki A, Jazi AHD, Safari S, Mahjoubi M, Sheikhbahaei E, Kermansaravi M. Long-Term Weight Loss Outcomes of One Anastomosis Gastric Bypass: Assessment of 1971 Patients with 5-9-Year Follow-Up. Obes Surg. 2025 Jan;35(1):102-111. doi: 10.1007/s11695-024-07618-2. Epub 2024 Dec 14.

    PMID: 39674852BACKGROUND

  • Angrisani L, Santonicola A, Iovino P, Palma R, Kow L, Prager G, Ramos A, Shikora S; Collaborative Study Group for the IFSO Worldwide Survey. IFSO Worldwide Survey 2020-2021: Current Trends for Bariatric and Metabolic Procedures. Obes Surg. 2024 Apr;34(4):1075-1085. doi: 10.1007/s11695-024-07118-3. Epub 2024 Mar 4.

    PMID: 38438667BACKGROUND

  • Bekheit M, Ibrahim MY, Tobar W, Galal I, Elward AS. Correlation Between the Total Small Bowel Length and Anthropometric Measures in Living Humans: Cross-Sectional Study. Obes Surg. 2020 Feb;30(2):681-686. doi: 10.1007/s11695-019-04238-z.

    PMID: 31686382BACKGROUND

  • Pizza F, D'Antonio D, Lucido FS, Tolone S, Dell'Isola C, Gambardella C. Postoperative Clinical-Endoscopic Follow-up for GERD and Gastritis After One Anastomosis Gastric Bypass for Morbid Obesity: How, When, and Why. Obes Surg. 2020 Nov;30(11):4391-4400. doi: 10.1007/s11695-020-04805-9. Epub 2020 Jul 3.

    PMID: 32621053BACKGROUND

  • Carbajo MA, Luque-de-Leon E, Jimenez JM, Ortiz-de-Solorzano J, Perez-Miranda M, Castro-Alija MJ. Laparoscopic One-Anastomosis Gastric Bypass: Technique, Results, and Long-Term Follow-Up in 1200 Patients. Obes Surg. 2017 May;27(5):1153-1167. doi: 10.1007/s11695-016-2428-1.

    PMID: 27783366BACKGROUND

  • Almuhanna M, Soong TC, Lee WJ, Chen JC, Wu CC, Lee YC. Twenty years' experience of laparoscopic 1-anastomosis gastric bypass: surgical risk and long-term results. Surg Obes Relat Dis. 2021 May;17(5):968-975. doi: 10.1016/j.soard.2021.01.010. Epub 2021 Jan 21.

    PMID: 33619007BACKGROUND

  • Abu-Abeid A, Ovadya R, Gosher N, Yuval JB, Bendayan A, Keidar A, Eldar SM. Tailored Biliopancreatic Limb Length to 40% of Total Small Bowel Length in One Anastomosis Gastric Bypass (TABLE-40): Protocol of a Prospective Randomized Controlled Trial. Obes Surg. 2025 Sep;35(9):3619-3625. doi: 10.1007/s11695-025-08035-9. Epub 2025 Jul 10.

    PMID: 40638030DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Central Study Contacts

Adam Abu-Abeid, M.D

CONTACT

+972524266283adama@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Adam-Abu Abeid - Assistant Professor, Consultant Bariatric Surgeon

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

January 29, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)