Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis

Completed

• Conditions: Microcirculation; Circulatory; Change

• Registration Number: NCT03724162
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-16
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-30
• Status Verified: 2020-10
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery	6 months	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.

Trial Locations

Locations (2)

Department of vascular surgery, Oslo University Hospital; 🇳🇴 Oslo, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway