Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery

NCT02507414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2016-10-05

No results posted yet for this study

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.

Conditions

  • Gastrointestinal Neoplasms
  • Mesenteric Traction Syndrome

Interventions

OTHER

Blood samples

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

OTHER

Measurement of microcirculation

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.

OTHER

Head down tilt

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)

Sponsors & Collaborators

  • Danish Cancer Society

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02507414 on ClinicalTrials.gov