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

NCT ID: NCT04367987

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-17

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery--Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing colorectal surgery

Heart Rate Variability

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Heart Rate Variability

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Bertrand

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU de Nimes

Nîmes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Martin Bertrand

Role: CONTACT

04.66.68.68.09

Facility Contacts

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Anissa Megzari

Role: primary

04.66.68.42.36

Other Identifiers

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Local/2018/MB-01

Identifier Type: -

Identifier Source: org_study_id

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