CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
Blood samples +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02507414
NCT02507414N/ACompleted

Characterization of the Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery for Malignant Disease

Rigshospitalet, Denmark·interventional·Posted Jul 24, 2015·Updated Oct 5, 2016

In Brief

A clinical study evaluating Blood samples, Measurement of microcirculation, and 1 other intervention for Gastrointestinal Neoplasms and Mesenteric Traction Syndrome. Completed, enrolled 75 participants.

Detailed Summary

It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of the syndrome is an important factor in provoking further peri- and postoperative complications and in worsening the surgical stress response (SSR). The characteristics of MTS is hypotension, tachycardia, and flushing. In order to uncover the role of MTS in cancer surgery and the effects on the oncological patients, the aim of the project is: 1\. To characterize MTS in patients undergoing three common forms of UGC surgery using a new objective methodology and by recording biomarkers suspected of playing a role in the pathophysiology of MTS and postoperative complication development. Three different interventions will be examined during this prospective trial: 1. Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast Imaging during surgery. 2. Analyses of plasma samples obtained pre-, intra-, and one day postoperatively. 3. Continuous measurements of haemodynamic variables during surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 24, 2015
Enrollment StartAug 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.9 years ago

Interventions

Blood samplesother

15 arterial blood samples (pre-, intra- and one day postoperatively); no more than 180ml in total over two days.

Measurement of microcirculationother

Measurement of microcirculation with Laser Speckle Contrast Imaging (non-touch setup with no side effects); continuous measurement of the microvascular blood flow on the forehead up to 60 minutes starting one minute before the surgical procedure.

Head down tiltother

At three different time points the participants will be head down tilted in 20 degrees. End of surgery (A) One hour postoperatively (B) 18 hours postoperatively (C)