Set up and Validation of Total Small Bowel Length Measurement Using Computed Tomography and Magnetic Resonance Imaging With 3D Reconstruction and Artificial Intelligence Tool in Obese Patients Candidates to Metabolic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Concordance between AI-based total small bowel length measure and laparoscopic total small bowel length measure
研究概览
简要总结
The aim of the study is to set up and validate a reliable and reproducible automated method using preoperative radiological imaging to measure the TSBL in patients undergoing laparoscopic bariatric/metabolic surgery.
详细描述
The total length of the small intestine (TSBL) represents a crucial parameter for obtaining a safe and successful minimally invasive surgery in metabolic/bariatric bypass surgery.
Nowadays, the standard of small intestine measurement is the intraoperative measurement. Laparoscopy represents the standard approach for baratric/metabolic, making the TSBL measurement time-consuming and risky in case of intestinal lesions. An accurate and effective non-invasive preoperative measurement of the TSBL will allow to evaluate the variability of the TSBL, which affects the surgical strategy. Cross-sectional imaging could play an important role in this setting thanks to the possibility of measuring in a non-invasive way the TSBL. Some studies performed with both Computed Tomography (CT) and Magnetic Resonance (MR) report promising results. However, they are limited by the small size of the sample, the lack of standardized technique and the lack of an automatic method based on Artificial Intelligence (AI).
The evaluation of a reliable preoperative method to measure TSBL using cross-sectional imaging will potentially reduce intraoperative complications and insufficient long-term weight loss or nutritional deficiencies. In this scenario a possible solution could be the implementation of analysis method through the development of an AI algorithm capable of automatically segmenting the small intestine.
The PRIMARY END POINT of this study is to set up and validate a reliable and reproductible automatic method to measure the TSBL in patients candidates for laparoscopic bariatric/metabolic surgery, based on preoperative radiological imaging
The main phases of the project will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 35 kg/m2 and at least one obesity-related comorbidity
- •BMI > 40 kg/m2
- •failure of at least six months of dietary and/or medical treatment of obesity
- •indication for intervention validated after multidisciplinary evaluation in a specific board meeting
排除标准
- 未提供
结局指标
主要结局
Concordance between AI-based total small bowel length measure and laparoscopic total small bowel length measure
时间窗: 1 month
the main outcome is to set up and validate a reliable and reproducible automated method using preoperative radiological imaging to measure the TSBL in patients candidates for laparoscopic bariatric/metabolic surgery. The results of AI measurement will be compared with those of laparoscopic measurement to examine the level of concordance
次要结局
未报告次要终点
研究者
Niccolo Petrucciani
MD, PhD, Associate Professor of Surgery
University of Roma La Sapienza
