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在单吻合口胃旁路手术中将胆胰肢长度调整为小肠总长度的40%(表40):一项前瞻性随机对照试验方案

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.

作者信息

Abu-Abeid Adam, Ovadya Ronli, Gosher Noa, Yuval Jonathan Benjamin, Bendayan Anat, Keidar Andrei, Eldar Shai Meron

机构信息

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Tel Aviv University, Tel Aviv, Israel.

出版信息

Obes Surg. 2025 Jul 10. doi: 10.1007/s11695-025-08035-9.

Abstract

BACKGROUND

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.

METHODS

This multicenter, prospective, randomized trial will enroll at least 200 participants undergoing OAGB across three centers. Participants, aged 18 and older, will be randomized into two groups: one group will undergo a tailored BPL length based on TSBL (40%), while the control group will receive a standard BPL length of 180 cm. The primary endpoint is comparison of total weight loss after 1 and 3 years. Secondary endpoints include postoperative complications, quality of life, and improvements in obesity-related diseases.

RESULTS

The study will collect and analyze data as outlined in the protocol. The results will be reported upon completion of data collection and analysis.

CONCLUSIONS

The TABLE-40 study will provide robust evidence on whether tailoring the BPL to 40% of TSBL offers higher weight loss outcomes compared to a fixed-length approach in OAGB. By assessing both efficacy and safety across multiple centers, the trial aims to inform best practices in limb length selection and optimize long-term outcomes for patients undergoing OAGB.

TRIAL REGISTRATION

This study was registered at Clinicaltrials.gov (NCT06829381) on 29/1/2025.

摘要

背景

单吻合口胃旁路术(OAGB)是以色列最常见的代谢和减重手术(MBS),因其在实现可持续体重减轻和减轻肥胖相关疾病方面的有效性而得到认可。OAGB的代谢结果受胆胰支(BPL)长度的显著影响。本研究的目的是确定根据总小肠长度(TSBL)调整BPL长度与接受180cm固定BPL的OAGB患者相比,是否能实现更有效的体重减轻。还将评估这种方法的有效性和安全性,确保其不会导致长期发病或对患者生活质量产生负面影响。

方法

这项多中心、前瞻性、随机试验将在三个中心招募至少200名接受OAGB的参与者。年龄在18岁及以上的参与者将被随机分为两组:一组将根据TSBL进行BPL长度调整(40%),而对照组将接受180cm的标准BPL长度。主要终点是比较1年和3年后的总体重减轻情况。次要终点包括术后并发症、生活质量以及肥胖相关疾病的改善情况。

结果

该研究将按照方案收集和分析数据。数据收集和分析完成后将报告结果。

结论

TABLE - 40研究将提供有力证据,证明在OAGB中,与固定长度方法相比,将BPL调整为TSBL的40%是否能带来更高的体重减轻效果。通过在多个中心评估有效性和安全性,该试验旨在为肢体长度选择的最佳实践提供参考,并优化接受OAGB患者的长期结局。

试验注册

本研究于2025年1月29日在Clinicaltrials.gov(NCT06829381)注册。

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