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NCT03724162 Clinical Trial

Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis

Microcirculation Clinical Trial

Official title:
Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03724162
Other study ID # LDFLVS Ca oesophagus
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 16, 2018
Est. completion date October 1, 2020

Study information
Verified date October 2020
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.

Description:

- Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included.

Exclusion Criteria: Patients who do not give written consent will not be included.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Department of vascular surgery, Oslo University Hospital Oslo
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery Repeated measurements of microcirculation With laser dopper flometer and visible light spectrometry shall be performed trans serosally of the stoach and gastric tube to register changes in microcirculation. Patients shall be followed up for anastomotic leaks. Besides CT angiography shall be performed before surgery. 6 months
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