- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04996511
Day Case Colectomy: Optimizing Short Stay-surgery.
February 17, 2024 updated by: Joint Authority for Päijät-Häme Social and Health Care
HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.
Study Overview
Detailed Description
Patients scheduled for colorectal surgery are recruited to the study.
HRV parameters including e.g.
RMSSD are evaluated before and after surgery.
The effect of surgery and possible complications associated with it on parameters and relationship with specific adverse effects caused by complications are evaluated.
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Juha KA Rinne, MD
- Phone Number: +358 03 81911
- Email: juha.rinne@phhyky.fi
Study Contact Backup
- Name: Jyrki AO Kössi, Adjunct.Prof
- Phone Number: +358 03 81911
- Email: jyrki.kossi@phhyky.fi
Study Locations
-
-
-
Lahti, Finland, 15850
- Recruiting
- Päijät-Häme Central hospital
-
Contact:
- Juha KA Rinne, MD
- Phone Number: +358 0381911
- Email: juha.rinne@phhyky.fi
-
Contact:
- Jyrki AO Kössi, Adjunct Prof
- Phone Number: +358 0381911
- Email: jyrki.kossi@phhyky.fi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Colorectal resection for any pathology
Exclusion Criteria:
• Arrhytmias likely to cause problems with HRV measurements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Colorectal Surgery Patients
|
Postoperative HRV measurement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability (HRV) change
Time Frame: 3 days
|
Reliability of HRV parameters
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Juha KA Rinne, MD, Päijät Häme Central Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
May 5, 2021
First Submitted That Met QC Criteria
July 30, 2021
First Posted (Actual)
August 9, 2021
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 17, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Q021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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