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临床试验/NCT05338567
NCT05338567Unknown不适用

Digital Three-dimensional Reconstruction for Predicting Small Bowel Length in Bariatric Surgery

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年10月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Validation of the accuracy of the predicted length of the small intestine

研究概览

简要总结

The prevalence of type 2 diabetes mellitus (T2DM) has been increasing annually worldwide, and the prevalence of diabetes has reached 11.6% in China. Laparoscopic Roux-en-Y gastric bypass (RYGB) is still widely accepted as a valid surgery in the treatment of obesity and T2DM. But still, there is no consensus on the ideal of the gastric bypass limb lengths. Reported lengths of biliopancreatic limb (BPL) and alimentary limb (AL) varied widely from 10-250 to 35-250 cm, and anatomical data show that the length of small intestine varies greatly among adults. Choosing the same small bowel bypass length for different individuals obviously cannot achieve the expected weight loss effect, and individuals with too short small intestine can cause severe malnutrition complications and even life-threatening conditions. Therefore, measurement of small bowel length is one of the prerequisites for performing precise RYGB. Intraoperative measurement of small bowel length can increase the operative time and the risk of surgical complications such as intestinal perforation. So, predicting the total length of the small intestine is very important for accurately performing bariatric surgery and avoiding the risk of surgical complications. In this study, we propose to perform 3D segmentation and reconstruction of the small intestine by acquiring abdominal CT data through digital technology, and predict the small intestine length by 3D digital measurement of the small intestine, and verify the digital measurement data by performing digital measurement data. Establish a small bowel length prediction model for bariatric surgery to develop a more accurate and personalized gastric bypass surgery plan for patients to obtain weight loss and glucose control.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients eligible for surgical treatment of T2DM were selected based on the Chinese Guidelines for the Surgical Treatment of Obesity and Type 2 Diabetes (2019 )

排除标准

  • Adhesions, peritonitis, and patients who have had bowel resection (small intestine, colon or rectum) that hinder the measurement of the entire intestinal length
  • Non-weight loss surgery patients whose incision is less than 6 cm are not suitable for measuring the length of the small intestine.

结局指标

主要结局

Validation of the accuracy of the predicted length of the small intestine

时间窗: 2 years

The accuracy of the 3D reconstruction method was judged by comparing the length of the small intestine measured by the open/laparoscopic surgery with the length of the small intestine calculated by the preoperative CT 3D reconstruction.

次要结局

  • Building prediction formulas through machine deep learning(2 years)

研究者

发起方
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

fan li

DapingH

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

研究点 (1)

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