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CompletedNCT02343601PANEX3Updated Apr 2, 2026

Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

A Phase 3 interventional study of Photoplethysmography in Polyp of Large Intestine, Colorectal Neoplasms and Crohn Disease, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by University Hospital, Caen · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
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Study summary

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.

Read the detailed description

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

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Conditions studied

  • Polyp of Large Intestine
  • Colorectal Neoplasms
  • Crohn Disease
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 160 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age> 18 years
  • Colorectal surgery

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

  • 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

Interventions

  • DevicePhotoplethysmography

    Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

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What researchers measure

Primary outcomes

  1. Incidence of patients presenting at least one complication after colorectal surgery

    Two independent experts defined the presence of complication using an a priori classification.

    Time frame: Up to 28 days after surgery (length of hospital stay)

Secondary outcomes

  1. All complications happening after colorectal surgery

    Time frame: Up to 28 days after surgery (length of hospital stay)

  2. Real length of hospital stay

    Time frame: Up to 28 days after surgery (length of hospital stay)

  3. Perioperative mortality

    Time frame: 28 days after surgery

Other outcomes

  1. Medico economic evaluation of cost of treatment

    Medico economic evaluation of photoplethysmography use will be assessed with a specific unit of measure, using cost of treatment.

    Time frame: Up to 28 days after surgery (length of hospital stay)

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Study locations

1 site
  • Caen University Hospital
    Caen, 14 000, France
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References and documents

Publications

  • Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gerard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4. PubMed 27004412 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02343601
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Jan 22, 2015
Start date
Dec 2014
Primary completion
Oct 2016
Completion
Dec 2016
Last update
Apr 2, 2026

Study contacts

Anne-Lise Fiant, MD
principal investigator · University Hospital of Caen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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