Surgery--ComplicationsVFC COLORECTALNCT04367987
Variability of Heart Rate as a Marker of Complication of Colorectal Surgery
An observational study of Surgery--Complications, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Heart Rate Variability
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2020to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing scheduled colorectal resection or operated on in the digestive surgery department of the CHU Nîmes
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nimes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Martin Bertrand
About this study
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.
- Conditions
- Surgery--Complications
- Being tested
- Heart Rate Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate VariabilityDiagnostic test
Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing colorectal surgery | Not described Receives: Diagnostic Test: Heart Rate Variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
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
Measured: Hospital discharge (maximum Day 7)
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
Measured: Hospital discharge (maximum Day 7)
Secondary outcomes (12)
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
Measured: Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscess
Measured: Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumonia
Measured: Hospital 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 infection
Measured: Hospital 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 infection
Measured: Hospital 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 hematoma
Measured: Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shock
Measured: Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate
Measured: Hospital 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 thrombosis
Measured: Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolism
Measured: Hospital 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 edema
Measured: Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart disease
Measured: Hospital discharge (maximum Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start17 Jun 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Bertrand, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367987
- Sponsor's protocol ID
- Local/2018/MB-01
- Acronym
- VFC COLORECTAL
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability of Heart Rate as a Marker of Complication of Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04367987
- Acronym / sponsor ID
- VFC COLORECTAL / Local/2018/MB-01
- Conditions
- Surgery--Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing colorectal surgery | – | Diagnostic Test: Heart Rate Variability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing scheduled colorectal resection or operated on in the digestive surgery department of the CHU Nîmes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate VariabilityHeart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software | Diagnostic test | Patients undergoing colorectal surgery |
Primary outcome
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
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
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
12 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Bertrand principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Bertrand (04.66.68.68.09, martin.bertrand@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of variability of the heart rate between Day-1 to Day 7 (time frame: Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.