Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-25

Study Completion Date

2019-03-04

Brief Summary

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Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage

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Detailed Description

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The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient.

Conditions

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Microdialysis Ischemia Anastomotic Leakage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Microdialysis catheter

Surface Microdialysis catheter will be placed onto the surgical reconstruction after esophagectomy and will be evaluated for clinical safety and performance. The metabolic profile as measured by Microdialysis will be correlated to the clinical outcome. No interventions based on the results will be performed.

Group Type EXPERIMENTAL