Tailored One Anastomosis Gastric Bypass
ConditionMetabolic and Bariatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTel-Aviv Sourasky Medical Center
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) undergoing OAGB
Disqualifiers
Patients <18 years, pregnant women, or those lacking decision-making capacity Prior bariatric surgery Short bowel (<450 cm)
Trial design
Design model
Parallel
Treatments tested in this trial
Tailored BPL length
Procedure/SurgeryTotal bowel length measure and BPL will be 40% of total bowel length ensuring at least 250 cm common channel
Control - BPL 180 cm
Procedure/SurgeryTotal bowel length measure and BPL will be180 cm
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Control group BPL 180 cmActive comparator 1 intervention
Group B: Tailored BPL lengthExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
weight loss
Total weight loss will be calculated as - preoperative weight-last follow-up weight/preoperative weight \* 100
Time frame
6 months, one year, and 3 years after surgerySecondary outcomes
1
Postoperative nutritional complications
Postoperative nutritional complications - albumin, vitamins, iron
Time frame
6 months and one year after surgery2
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.
Time frame
6 months and one year postopertively3
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).
Time frame
6 months and one year postopertively4
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.
Time frame
6 months, 1 year and 3 yearsSponsors and contacts
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Source ClinicalTrials.gov