Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery (POETRYminor)

January 29, 2018 updated by: Sarah Victoria Ekeløf Busch, Zealand University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

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

  • Denmark
      • Køge, Denmark, 4600
        • Department of Surgery, Koge Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators expect that minor surgery will reduce the reactive hyperemia index assessed 4 hours postoperatively with 15% equal to 1.59. With a power of 0.80 and α on 0.05, the investigators will need to include 54 patients in this study. In order to improve the power of the study, the investigators will include a total of 60 patients.

Description

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

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
Time Frame
Change in endothelial function assessed by the EndoPat system
Time Frame: At baseline and 4 hours postoperatively
At baseline and 4 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in biomarkers of endothelial function: plasma arginine, plasma ADMA, plasma biopterins
Time Frame: At baseline and 4 hours postoperatively
At baseline and 4 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Sarah VE Busch, MD, Department of Surgery, Køge Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • POETRY minor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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