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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

All patients undergoing scheduled colorectal resection or operated on in the digestive surgery department of the CHU Nîmes

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Heart Rate Variability

    Diagnostic test

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

Treatment groups

117 Participants
are divided into 1 treatment group
Group A: Patients undergoing colorectal surgery1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Day 7
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

Abdominal-pelvic imagery

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 peri-anastomotic fluid collections after scheduled colorectal surgery

Abdominal-pelvic imagery

Time frame
Hospital discharge (maximum Day 7)

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

diagnosed on CT-scan

Time frame
Hospital discharge (maximum Day 7)
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)

Other outcomes

Sponsors and contacts

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