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RecruitingNCT04996511Updated Apr 22, 2026

Day Case Colectomy: Optimizing Short Stay-surgery.

An interventional study of PulseOn in Monitoring, Physiologic, sponsored by Joint Authority for Päijät-Häme Social and Health Care. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Joint Authority for Päijät-Häme Social and Health Care · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jan 2020, registered May 2021).
  • Started Jan 2020; still recruiting 6 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.

Read the 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.

02

Conditions studied

  • Monitoring, Physiologic
03

In context

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Colorectal resection for any pathology

Exclusion criteria

Exclusion Criteria:

  • Arrhytmias likely to cause problems with HRV measurements
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Colorectal Surgery Patients

    Device: PulseOn

Interventions

  • DevicePulseOn

    Postoperative HRV measurement

    Also known as: Faros, Emfit QS

06

What researchers measure

Primary outcomes

  1. Heart Rate Variability (HRV) change

    Reliability of HRV parameters

    Time frame: 3 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Miri S, Rinne JKA, Kossi J, Oksala N, Vehkaoja A. Postoperative stress assessment using PPG-based heart rate variability and exploratory ECG analysis in colorectal surgery. Scand J Clin Lab Invest. 2026 Jul 16:1-13. doi: 10.1080/00365513.2026.2703029. Online ahead of print. PubMed 42461792 ↗
  • Rinne JKA, Miri S, Oksala N, Vehkaoja A, Kossi J. Evaluation of a wrist-worn photoplethysmography monitor for heart rate variability estimation in patients recovering from laparoscopic colon resection. J Clin Monit Comput. 2023 Feb;37(1):45-53. doi: 10.1007/s10877-022-00854-w. Epub 2022 Apr 8. PubMed 35394583 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04996511
Lead sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
Tampere University
Responsible party
Sponsor
First posted
Aug 9, 2021
Start date
Jan 1, 2020
Primary completion
May 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Juha KA Rinne, MD
Contact
juha.rinne@phhyky.fi
03 81911 ext. +358
Jyrki AO Kössi, Adjunct.Prof
Contact
jyrki.kossi@phhyky.fi
03 81911 ext. +358
Juha KA Rinne, MD
principal investigator · Päijät Häme Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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