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临床试验/NCT06829381
NCT06829381招募中不适用

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

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
weight loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥18 years) undergoing OAGB

排除标准

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

研究组 & 干预措施

Control group BPL 180 cm

Active Comparator

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

干预措施: Control - BPL 180 cm (Procedure)

Tailored BPL length

Experimental

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

干预措施: Tailored BPL length (Procedure)

结局指标

主要结局

weight loss

时间窗: 6 months, one year, and 3 years after surgery

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

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shmuel Kivity, MD

Dr Adam-Abu Abeid - Assistant Professor, Consultant Bariatric Surgeon

Tel-Aviv Sourasky Medical Center

研究点 (1)

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