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Clinical Trials/NCT02690233
NCT02690233
Completed
Not Applicable

Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery. The POETRY Minor Study.

Zealand University Hospital1 site in 1 country60 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myocardial Injury
Sponsor
Zealand University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change in endothelial function assessed by the EndoPat system
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study on minor surgery serves to explore whether a dose-response relationship exists between surgical stress and endothelial dysfunction in the early postoperative period. The aim of this explorative and observational clinical study is to closely examine the endothelial function and its dynamics in the early postoperative period after minor surgery (lap. inguinal hernia repair). The endothelial function will be assessed indirectly by EndoPat and plasma biomarkers of nitric oxide bioavailability. The study will contribute to the understanding of perioperative myocardial injury, which is crucial for optimized treatment of patients at risk of cardiovascular complications.

Detailed Description

The investigators will include 60 patients undergoing elective inguinal hernia repair. The endothelial function will be measured before surgery and 4 hours after surgery with the EndoPat system. The NO-bioavailibility will be measured by plasma l-arginine, plasma ADMA and plasma biopterins.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
June 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Victoria Ekeløf Busch

MD

Zealand University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for a laparoscopic inguinal hernia repair
  • Patients ≥ 18 years old

Exclusion Criteria

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial  - Surgery within 7 days of the trial

Outcomes

Primary Outcomes

Change in endothelial function assessed by the EndoPat system

Time Frame: At baseline and 4 hours postoperatively

Secondary Outcomes

  • Change in biomarkers of endothelial function: plasma arginine, plasma ADMA, plasma biopterins(At baseline and 4 hours postoperatively)

Study Sites (1)

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