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Clinical Trials in France / NCT04367987
Recruiting Observational

Variability of Heart Rate as a Marker of Complication of Colorectal Surgery

NCT04367987 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nīmes
Phase
Observational
Started
2020-06-17
Last updated
2026-06-16

Condition(s) studied

Surgery--Complications

Investigational drug(s) / intervention(s)

Heart Rate Variability

Heart Rate Variability: Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software

Study summary

Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients operated for a scheduled colorectal resection due to cancer, diverticulitis, or Chronic Inflammatory Bowel Disease, * American Society of Anesthesiologists score 1-2 * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * Patient taking antidepressants, antipsychotics, antihypertensive beta blocker type, anti-arythmic or oral contraception * Uncontrolled diabetes or associated with a neuropathy * Arrhythmias and conduction disturbances, , coronaropathy and heart failure, kidney failure * Neuropathies * Pacemaker or defibrillator * The subject is participating in another interventional study, or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship

Primary outcome measure(s)

  • Rate of variability of the heart rate between Day-1 to Day 7 — Day 7
    Measured by power spectral density; ratio of the high to low frequencies
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7and anastomotic fistula diagnosed according to Center for Diseases Control criteria after scheduled colorectal surgery — Hospital discharge (maximum Day 7)
    Abdominal-pelvic imagery
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and peri-anastomotic fluid collections after scheduled colorectal surgery — Hospital discharge (maximum Day 7)
    Abdominal-pelvic imagery

Trial sites (1)

FacilityCityRegionStatus
CHU de Nimes Nîmes France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04367987 on ClinicalTrials.gov ↗ ← All trials in France