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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04367987
Acronym
VFC COLORECTAL
Enrollment
117
Registered
2020-04-29
Start date
2020-06-17
Completion date
2027-06-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery--Complications

Brief 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.

Interventions

DIAGNOSTIC_TESTHeart Rate Variability

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

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of variability of the heart rate between Day-1 to Day 7Day 7Measured 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 surgeryHospital 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 surgeryHospital discharge (maximum Day 7)Abdominal-pelvic imagery

Secondary

MeasureTime frameDescription
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscessHospital discharge (maximum Day 7)diagnosed on CT-scan
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscessHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumoniaHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of urinary tract infectionHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of central venous catheter infectionHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal hematomaHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shockHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rateHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of deep vein thrombosisHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolismHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of acute pulmonary edemaHospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart diseaseHospital discharge (maximum Day 7)

Countries

France

Contacts

CONTACTMartin Bertrand
martin.bertrand@chu-nimes.fr04.66.68.68.09
PRINCIPAL_INVESTIGATORMartin Bertrand

CHU Nimes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026