Clinical trial NCT02690233: Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery
Official title: Perioperative Endothelial Dysfunction in Patients Undergoing Minor Abdominal Surgery. The POETRY Minor Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Injury
Keywords: endothelial dysfunction
surgery
cardiovascular complications
EndoPat
myocardial injury
myocardial infarction
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in endothelial function assessed by the EndoPat system
timeFrame: At baseline and 4 hours postoperatively
Secondary outcomes:
measure: Change in biomarkers of endothelial function: plasma arginine, plasma ADMA, plasma biopterins
timeFrame: At baseline and 4 hours postoperatively
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Surgery, Koge Hospital
Study officials:
affiliation: Department of Surgery, Køge Hospital
name: Sarah VE Busch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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