Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery (PANEX3)

March 30, 2026 updated by: University Hospital, Caen

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study

The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14 000
        • Caen University Hospital

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 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age> 18 years
  • Colorectal surgery

Exclusion Criteria:

  • Pregnant women
  • Black skin
  • Chronic renal insufficiency (MDRD <30 ml/min)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Control group using a hemodynamic standard protocol
Other: Photoplethysmography group
Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)
Device: Photoplethysmography
Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of patients presenting at least one complication after colorectal surgery
Time Frame: Up to 28 days after surgery (length of hospital stay)
Two independent experts defined the presence of complication using an a priori classification.
Up to 28 days after surgery (length of hospital stay)

Secondary Outcome Measures

Outcome Measure
Time Frame
All complications happening after colorectal surgery
Time Frame: Up to 28 days after surgery (length of hospital stay)
Up to 28 days after surgery (length of hospital stay)
Real length of hospital stay
Time Frame: Up to 28 days after surgery (length of hospital stay)
Up to 28 days after surgery (length of hospital stay)
Perioperative mortality
Time Frame: 28 days after surgery
28 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medico economic evaluation of cost of treatment
Time Frame: Up to 28 days after surgery (length of hospital stay)
Medico economic evaluation of photoplethysmography use will be assessed with a specific unit of measure, using cost of treatment.
Up to 28 days after surgery (length of hospital stay)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Anne-Lise Fiant, MD, University hospital of Caen

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.

General Publications

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)

December 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimated)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00870-47

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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