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Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03724162
Collaborator
(none)
12
Enrollment
2
Locations
26.5
Actual Duration (Months)
6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    12 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma
    Actual Study Start Date :
    Jul 16, 2018
    Actual Primary Completion Date :
    Oct 1, 2020
    Actual Study Completion Date :
    Oct 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital Oslo Norway 0424
    2 Department of vascular surgery, Oslo University Hospital Oslo Norway

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Syed Sajid Hussain Kazmi, Consultat Vascular Surgeon, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03724162
    Other Study ID Numbers:
    • LDFLVS Ca oesophagus
    First Posted:
    Oct 30, 2018
    Last Update Posted:
    Oct 6, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Syed Sajid Hussain Kazmi, Consultat Vascular Surgeon, Oslo University Hospital
    cancer oesophagus

    Study Results

    No Results Posted as of Oct 6, 2020