- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724162
Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis
October 4, 2020 updated by: Syed Sajid Hussain Kazmi, Oslo University Hospital
Impact of Circulatory Changes on Thoracic Anastomosis in Patients Undergoing Thoracolaparoscopic Surgery for Oesophageal Carcinoma
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oslo, Norway, 0424
- Oslo University Hospital
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Oslo, Norway
- Department of vascular surgery, Oslo University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Only subjects selected for thoracolaparoscopic operation shall be included in this study.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 16, 2018
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
July 26, 2018
First Submitted That Met QC Criteria
October 26, 2018
First Posted (Actual)
October 30, 2018
Study Record Updates
Last Update Posted (Actual)
October 6, 2020
Last Update Submitted That Met QC Criteria
October 4, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LDFLVS Ca oesophagus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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