Day Case Colectomy: Optimizing Short Stay-surgery. | NCT04996511

Studies
Day Case Colectomy: Optimizing Short Stay-surgery.

NCT04996511

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Status

Recruiting

Last Update Posted

Apr 22, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Monitoring, Physiologic

Interventions

PulseOn

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

May 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 5, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 22, 2026Actual

Name	Class
Tampere University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colorectal Surgery Patients	Experimental		Device: PulseOn

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PulseOn	Device	Postoperative HRV measurement	Colorectal Surgery Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart Rate Variability (HRV) change	Reliability of HRV parameters	3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Colorectal resection for any pathology

Exclusion Criteria:

• Arrhytmias likely to cause problems with HRV measurements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juha KA Rinne, MD	Contact	03 81911	+358	juha.rinne@phhyky.fi
Jyrki AO Kössi, Adjunct.Prof	Contact	03 81911	+358	jyrki.kossi@phhyky.fi

Overall Officials

Name	Affiliation	Role
Juha KA Rinne, MD	Päijät Häme Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Päijät-Häme Central Hospital	Recruiting	Lahti		15850	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35394583	Derived	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.