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Intraoperative Measuring of Small Bowel Length Compared to Measuring by Magnetic Resonance Imaging (MRI) in Morbid Obese Patients

2012年12月19日 更新者:University Hospital Inselspital, Berne

Prospective Study for the Quantification of a Compensatory Increase in Small Bowel Length After Roux-en-Y Gastric Bypass in Morbid Obese Patients by Pre- and Postoperative Length-Measuring With MRI Compared to Intraoperative Length-Measuring

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length. At several reoperations we found a length increase of the lowest part of the small intestine of up to 80% compared to the measured length at the initial operation. On the one hand, this reflects a normal technical error of small bowel measuring due to the variable state of contraction of the bowel, but on the other hand, it could also be due to a compensatory increase in intestinal length after the operation. New protocols allow measuring of the small bowel length by MRI. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase. We plan to include 20 patients in this study.

研究概览

地位

终止

详细说明

Background:

An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length in order to define the lengths of the alimentary, biliopancreatic and common channel. The measuring itself is technically simple but has always an error due to the variable state of contraction of the small bowel. In distal gastric bypass a common channel length of 100 to 150 cm is chosen which induces an iatrogenic short bowel syndrome. At several reoperations we found a length increase of the common channel of up to 80% compared to the measured length at the initial operation. Former studies seem to indicate that an adaptation of small bowel length may occur in animals with short bowel syndrome or after intestinal bypass surgery. Longterm results of gastric bypass surgery often show weight regain after 3 to 5 years which could be due to the afore mentioned compensatory mechanism.

Newer MRI protocols allow for non-invasive measurement of the small bowel length. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase.

Objective:

In-vivo verification of small bowel length measurements made by MRI, quantification of a possible increase of the common channel length in the long run after distal gastric bypass.

Methods:

The preoperative small bowel length measurement by MRI is compared to the length measured intraoperatively. MRIs before discharge postoperatively as well as after 6 and 12 months are used to detect an eventual increase of the common channel length.

研究类型

观察性的

注册 (实际的)

7

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bern、瑞士、3010
        • Department of Visceral and Transplantsurgery, Bern University Hopsital
      • Bern、瑞士、3010
        • Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Morbid obese patients scheduled for distal gastric bypass

描述

Inclusion Criteria:

  • morbid obese patient
  • scheduled for distal gastric bypass
  • informed consent for operation and study obtained

Exclusion Criteria:

  • history of former small bowel resection
  • weight > 150 kg
  • history of claustrophobia
  • general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
1
Distal gastric bypass
Distal gastric bypass

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Small bowel length in vivo compared to measurements by MRI
大体时间:preoperative, previous to hospital discharge, 6 and 12 months postoperative
preoperative, previous to hospital discharge, 6 and 12 months postoperative

次要结果测量

结果测量
大体时间
Compensatory increase of the common channel (small bowel) after distal bypass
大体时间:12 months postoperative
12 months postoperative
Correlation of longterm weight regain with increase of common channel length
大体时间:12 months postoperative
12 months postoperative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Jean-Marc Heinicke, MD、Department of Visceral and Transplant Surgery, Bern University Hospital
  • 首席研究员:Philipp C Nett, Dr、DRNN, Inselspital, Bern University Hospital, Switzerland

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年1月1日

初级完成 (实际的)

2010年7月1日

研究完成 (实际的)

2010年7月1日

研究注册日期

首次提交

2008年8月22日

首先提交符合 QC 标准的

2008年8月22日

首次发布 (估计)

2008年8月25日

研究记录更新

最后更新发布 (估计)

2012年12月20日

上次提交的符合 QC 标准的更新

2012年12月19日

最后验证

2012年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • KEK248_07

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