NCT02612883

Brief Summary

Tissue perfusion is a critical factor for tissue regeneration and healing of anastomoses. Compromised microperfusion in the area where the anastomosis is sited likely contributes to leaks, but until now there has not been an easy and reliable technique to intraoperatively evaluate microperfusion. Objectives: To assess the association of intraoperative flux measurement with postoperative outcome of patients undergoing major abdominal surgery. Trial design: Prospective observational study. Flux measurement will be carried out using the moorVMS-LDF DUAL CHANNEL Laser Doppler Blood Flow system. The flux probe will be applied on the respective organs (i.e. esophagus, stomach, liver, pancreas, colon, rectum) and measurements will be documented after a stable signal has been obtained.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

5 years

First QC Date

November 20, 2015

Last Update Submit

February 4, 2021

Conditions

Perfusion

Keywords

Flux measurement

Outcome Measures

Primary Outcomes (1)

  • Perioperative morbidity

    90 days after resection

Study Arms (5)

Esophagus

Measuring of tissue perfusion of the esophagus

Liver

Measuring of tissue perfusion of the liver

Stomach

Measuring of tissue perfusion of the stomach

Pancreas

Measuring of tissue perfusion of the pancreas

Colon

Measuring of tissue perfusion of the colon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing major abdominal surgery of liver, stomach, colon/rectum, esophagus, pancreas

You may qualify if:

  • Patients scheduled for elective major abdominal surgery including
  • Liver resection
  • Esophageal resection
  • Gastric resection
  • Colon/rectal resection
  • Pancreatic resection

You may not qualify if:

  • Expected lack of compliance
  • Impaired mental state or language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

Dresden, Saxony, 01307, Germany

Location

Study Officials

  • Christoph Reißfelder, MD

    Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 24, 2015

Study Start

November 18, 2015

Primary Completion

December 1, 2020

Study Completion

February 1, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations

DE(1)