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NCT Number: NCT04367987

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

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.

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Key information

Conditions

Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, France

Location status: Recruiting

Location contact

Anissa Megzari

CONTACT

[email protected]

04.66.68.42.36

Martin Bertrand

PRINCIPAL_INVESTIGATOR

Mihane Nayeri

SUB_INVESTIGATOR

Pauline Balenghien

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Heart Rate Variability

Diagnostic Test

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

Primary outcomes

  1. Rate of variability of the heart rate between Day-1 to Day 7

    Time frame: Day 7

    Measured by power spectral density; ratio of the high to low frequencies

  2. 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

    Time frame: Hospital discharge (maximum Day 7)

    Abdominal-pelvic imagery

  3. 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

    Time frame: Hospital discharge (maximum Day 7)

    Abdominal-pelvic imagery

Secondary outcomes

  1. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess

    Time frame: Hospital discharge (maximum Day 7)

    diagnosed on CT-scan

  2. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscess

    Time frame: Hospital discharge (maximum Day 7)

  3. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumonia

    Time frame: Hospital discharge (maximum Day 7)

  4. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of urinary tract infection

    Time frame: Hospital discharge (maximum Day 7)

  5. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of central venous catheter infection

    Time frame: Hospital discharge (maximum Day 7)

  6. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal hematoma

    Time frame: Hospital discharge (maximum Day 7)

  7. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shock

    Time frame: Hospital discharge (maximum Day 7)

  8. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate

    Time frame: Hospital discharge (maximum Day 7)

  9. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of deep vein thrombosis

    Time frame: Hospital discharge (maximum Day 7)

  10. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolism

    Time frame: Hospital discharge (maximum Day 7)

  11. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of acute pulmonary edema

    Time frame: Hospital discharge (maximum Day 7)

  12. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart disease

    Time frame: Hospital discharge (maximum Day 7)

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Bertrand

CONTACT

[email protected]

04.66.68.68.09

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: VFC COLORECTAL

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2020
Registry last updated
Jun 16, 2026

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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