NCT03724162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

July 26, 2018

Last Update Submit

October 4, 2020

Conditions

Circulatory; ChangeMicrocirculation

Keywords

cancer oesophagus

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Only subjects selected for thoracolaparoscopic operation shall be included in this study.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital

Oslo, 0424, Norway

Location

Department of vascular surgery, Oslo University Hospital

Oslo, Norway

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultat Vascular Surgeon

Study Record Dates

First Submitted

July 26, 2018

First Posted

October 30, 2018

Study Start

July 16, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)