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Metabolic and Bariatric SurgeryOAGB-TLNCT06829381

Tailored One Anastomosis Gastric Bypass

A study testing Tailored BPL length in people with Metabolic and Bariatric Surgery, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metabolic and Bariatric Surgery
What is being tested?
Tailored BPL length
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteIsrael
Study dates
29 Jan 2025to 31 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Adults (≥18 years) undergoing OAGB

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Adam Abu-Abeid, M.D contact

+972524266283

adama@tlvmc.gov.il

Israel1 site, 1 recruiting
  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Recruiting

Other trials in Israel

About this study

Official title: Tailoring One-Anastomosis Gastric Bypass Based on Total Small Bowel Length - A Randomized Controlled Trial

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.

Read the detailed description

Scientific Background and Rationale for the Study One-Anastomosis Gastric Bypass (OAGB) is the most common bariatric procedure in Israel [1]. Over the years, OAGB has been proven to be an effective surgery, yielding significant and sustained weight loss, improvement in obesity-related comorbidities, and a relatively low failure rate [2].

The procedure involves separating a long gastric pouch from the remaining stomach and creating an anastomosis between the pouch and a distant loop of the small intestine [3]. Since this procedure bypasses a relatively long intestinal segment (typically 150-200 cm), it results in malabsorption of carbohydrates, fats, proteins, and other nutrients. This malabsorption-related mechanism leads to greater weight loss compared to purely restrictive surgeries like sleeve gastrectomy [4].

The length of the bypassed segment, specifically the biliopancreatic limb (BPL), plays a critical role in determining the metabolic outcomes of OAGB. A longer BPL is associated with more significant weight loss and greater improvement in obesity-related diseases [5]. However, the ideal BPL length remains a topic of global debate. Some experts recommend measuring the total small bowel length (TSBL) or ensuring at least 250-300 cm of common channel (CC) to prevent pathological malabsorption in patients with a shorter bowel and to reduce the risk of weight regain in those with a longer bowel [3,6].

Currently, the most widely accepted approach is to standardize the BPL length at 150-200 cm, as studies have shown that this range minimizes the risk of nutritional deficiencies [7]. However, tailoring the BPL length to the patient's TSBL is an increasingly recognized strategy that may optimize outcomes by ensuring a more precise CC length, thereby reducing complications and improving long-term weight loss.

Study Objective To evaluate whether tailoring the BPL length to the TSBL results in more effective weight loss compared to a standard bypass length of 180 cm.

Study Endpoints BPL and TSBL lengths Weight progression during follow-up Postoperative nutritional complications Improvement in obesity-related comorbidities Study Participants Single-center cohort: 200 patients Multi-center cohort: 500 patients Participating centers: Ichilov Medical Center, Assuta Tel Aviv, Herzliya Medical Center Participant Recruitment and Informed Consent Process

Eligible participants (competent adults) will be invited to sign a digital informed consent form via the PM7 system. The process includes:

A face-to-face explanation Time for consideration An opportunity to ask questions The signed consent form will be stored digitally in PM7 and printed as needed. If digital signing is not possible, a paper form will be used. The process adheres to Regulation 169 and follows an updated consent protocol. Enrollment and consent will take place during the preoperative consultation at the bariatric clinic.

Inclusion Criteria Patients aged 18 and older scheduled for OAGB at Tel Aviv Sourasky Medical Center Exclusion Criteria Special populations - Patients under 18, pregnant women, individuals lacking decision-making capacity, etc.

Previous bariatric surgery Withdrawal Criteria TSBL < 450 cm, as this would prevent achieving a common channel length of at least 250-300 cm, increasing the risk of severe malabsorption and nutritional deficiencies (protein, vitamins, iron).

Study Methods and Design Randomization Process After enrollment and consent, participants will be randomly assigned to either the intervention or control group.

Surgical Interventions Intervention Group: The surgeon will manually measure TSBL intraoperatively and create a BPL equal to 40% of the TSBL. This ensures a minimum CC length of 250-300 cm, in line with standard OAGB recommendations.

Control Group: The surgeon will measure the TSBL but will create a fixed BPL of 180 cm, as per the current standard.

Postoperative Follow-Up Patients will undergo routine follow-up at 2 weeks, 1, 3, 6, and 12 months, and annually thereafter.

Data Collection and Privacy Identifiable patient information will be separated from the dataset by an authorized investigator.

The principal investigator will maintain the coding key in a password-protected file within the hospital network.

Data will remain within the hospital and not be shared externally. Statistical Analysis T-tests and chi-square tests will be used to compare baseline characteristics. Results will be reported in tables with standard deviation and p-values. Study Timeline and Duration Total study duration: 8 years from approval.

Being tested
Tailored BPL length, Control - BPL 180 cm
Keywords
one anastomosis gastric bypass, obesity, weight loss, tailoring
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored BPL lengthProcedure or surgery

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

  • Control - BPL 180 cmProcedure or surgery

    Total bowel length measure and BPL will be180 cm

Study groups in NCT06829381
Study groupRoleWhat they receive
Control group BPL 180 cmActive comparatorTotal bowel length measure and BPL will be 180 cm regardless of total small bowel length
Receives: Procedure: Control - BPL 180 cm
Tailored BPL lengthExperimentalTotal bowel length measure and BPL will be 40% of total bowel length ensuring at least 250 cm common channel
Receives: Procedure: Tailored BPL length

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight loss

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

    Measured: 6 months, one year, and 3 years after surgery

Secondary outcomes (4)
  1. Postoperative nutritional complications

    Postoperative nutritional complications - albumin, vitamins, iron

    Measured: 6 months and one year after surgery

  2. resolution of obesity related diseases

    Resolution of obesity related diseases - Type 2 diabetes, hypertension, hyperlipidemia.

    Resolution of diseases definition - If patients no longer required medications or other treatment methods prior to surgery. In case of type 2 diabetes, a value of Hba1c below 6.5% in addition to cessation of antidiabetic to define its resolution.

    Measured: 6 months and one year postopertively

  3. Bariatric Analysis and Reporting Outcome System score

    Bariatric Analysis and Reporting Outcome System score - quality of life assessment.

    The assessment will be as follows - ≥7.0 - Excellent 5.1 - 6.9 - Very Good 3.1 - 5.0 - Good 1.1 - 3.0 - Fair

    ≤1.0 - Failure Maximum score - 9 (in case of optimal condition and no complications occur) Minimum scire - Negative values (if severe complications occur).

    Measured: 6 months and one year postopertively

  4. Fecal Score

    Altered bowel habits-such as loose stools, increased frequency of defecation, and even fecal incontinence-can significantly impact quality of life following bariatric surgery. To evaluate these changes, we are using the semi-quantitative Stool Frequency and Consistency Score, also known as the Fecal Score (FS), to assess bowel movement patterns at 6, 12, and 36 months postoperatively. The FS (Fecal Score) is calculated based on fecal frequency and consistency. Fecal frequency is assessed using a 5-point scale: less than twice per week (1 point), every two days (2 points), once daily (3 points), twice daily (4 points), and more than twice daily (5 points). Fecal consistency is also scored on a 5-point scale: watery stools (5 points), loose stools (4 points), normal stools (3 points), firm stools (2 points), and hard stools associated with constipation (1 point). The FS is derived by summing the fecal frequency and consistency scores.

    Measured: 6 months, 1 year and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2025
  2. Study start29 Jan 2025
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829381
Sponsor's protocol ID
TLV-0586-24
Acronym
OAGB-TL
Status last verified
Jul 2025
First submitted
11 Feb 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35733198
  • 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.

    PubMed 38704199
  • 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.

    PubMed 27452299
  • 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.

    PubMed 32001477
  • 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.

    PubMed 34462270
  • 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.

    PubMed 27396549
  • 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.

    PubMed 19161935
  • 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.

    PubMed 15273542
  • 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.

    PubMed 38546967
  • 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.

    PubMed 33578635
  • 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.

    PubMed 23347671
  • 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.

    PubMed 37511777
  • 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.

    PubMed 31558409
  • 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.

    PubMed 38593760
  • 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.

    PubMed 39674852

Questions about this trial

What is this clinical trial studying?

A study testing Tailored BPL length in people with Metabolic and Bariatric Surgery, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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 Israel. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adam Abu-Abeid, M.D (+972524266283, adama@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weight loss (time frame: 6 months, one year, and 3 years after surgery). 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 NCT06829381, which also lists 21 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 24 Jul 2025.

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