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临床试验/NCT07296224
NCT07296224已完成不适用

Scannographic Predictive Factors of Changes in the Intraoperative Therapeutic Strategies During Metabolic Bariatric Surgery (MBS)

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2023年5月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
288
试验地点
1
主要终点
left liver volume scannographic measure

研究概览

简要总结

Background: Laparoscopic Roux-en-Y Gastric By-pass (LRYGB) is not always feasible due to intraoperative difficulties, necessitating a change during surgical procedure. Non-contrast abdominal CT scans is not recommended before bariatric surgery but could be informative and very few studies have evaluated the relevance of these scans. The primary objective was to identify CT scan criteria that could predict a change in the intraoperative therapeutic strategy during LRYGB. Secondary objectives included identifying clinical data associated with change of intraoperative strategy, the impact of surgeon's experience and evaluate postoperative complications.

Methods: The study was conducted in University Hospital of Nancy, France between October 2012 and December 2022. This retrospective matched-case-control study (1:3) compared patients with intraoperative change of strategy when LRYGB was initially planned (study group) versus matched patients who undergone LRYGB. Clinical, scannographic, surgical experience and postoperative complications data were collected in the two groups.

详细描述

Obesity is a multifactorial condition involving behavioral, environmental and genetic factors . Possible treatments for obesity include nutritional, dietary and cognitive-behavioral management, as well as pharmacological therapies and metabolic bariatric surgery (MBS) . These treatments must be combined and tailored to each patient.

Before the performance of MBS only an esogastroduodenal endoscopy with systematic biopsies for Helicobacter pylori is currently recommended . In France, abdominal ultrasound is added for detecting vesicular lithiasis . According to the American Society for Metabolic and Bariatric Surgery abdominal ultrasound is indicated in patients presenting biliary tract symptoms or liver disease . Non-contrast abdominal CT scan is not an aspect of the initial assessment in Europe or in the United States . To our knowledge, only one MBS team evaluated the value of preoperative CT scans for identifying silent pathologies and concluded that the value of CT scans were minimal . In Nancy University Hospital, a preoperative non-contrast abdominal CT scan is proposed to all patients scheduled for MBS to screen for incidental lesions, hiatal hernia not visible in endoscopy and left liver hypertrophy.

In Nancy University Hospital, a Laparoscopic Roux-en-Y gastric bypass (LRYGB) is preferentially performed. Due to surgical difficulties, LRYGB is not always an option for treatment. In these cases, a change in the surgical procedure may be needed. In very difficult cases, the performance of any MBS may be impossible.

The investigator hypothesizes that preoperative scannographic features-especially increased left liver volume (LLV) -are predictive of intraoperative strategy change during LRYGB, and that this risk is further influenced by patient history and surgeon experience.

Design This was a retrospective, single-center, observational case-control study conducted between 1st October 2012 and 31st December 2022 at the University Hospital of Nancy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients scheduled for LRYGB surgery at the Nancy University Hospital between 1st October 2012 and 31st December 2022 who underwent a change in intraoperative surgical strategy
  • patient who did not object to the collection of their data.
  • patients over the age of 18

排除标准

  • Patients who did not have a preoperative scan
  • patients who were lost to follow-up within 6 months of surgery

结局指标

主要结局

left liver volume scannographic measure

时间窗: between 1st October 2012 and 31st December 2022

the Left Liver Volume (LLV) was measured on an abdominal CT scan by a raidologist

次要结局

  • parietal thickness(between 1st October 2012 and 31st December 2022)
  • surgical experience, number of bariatric procedure done before the surgery studied (less than 100 procedures or more)(between 1st October 2012 and 31st December 2022)
  • Post operative morbidity(between 1st October 2012 and 30st June 2023)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

NOMINE-CRIQUI Claire

MD Head of endocrine surgery Unit

Central Hospital, Nancy, France

研究点 (1)

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