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Completed

NCT Number: NCT02690233

Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery

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.

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Key information

Conditions

Myocardial Injury Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Koge Hospital

Køge, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective Surgery

Procedure

Elective laparoscopic inguinal hernia repair

Primary outcomes

  1. Change in endothelial function assessed by the EndoPat system

    Time frame: At baseline and 4 hours postoperatively

Secondary outcomes

  1. Change in biomarkers of endothelial function: plasma arginine, plasma ADMA, plasma biopterins

    Time frame: At baseline and 4 hours postoperatively

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: POETRYminor

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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