Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery
PANEX3
1 other identifier
interventional
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 2, 2026
May 1, 2019
1.8 years
June 13, 2014
March 30, 2026
Conditions
Outcome Measures
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.
Up to 28 days after surgery (length of hospital stay)
Secondary Outcomes (3)
All complications happening after colorectal surgery
Up to 28 days after surgery (length of hospital stay)
Real length of hospital stay
Up to 28 days after surgery (length of hospital stay)
Perioperative mortality
28 days after surgery
Other Outcomes (1)
Medico economic evaluation of cost of treatment
Up to 28 days after surgery (length of hospital stay)
Study Arms (2)
Control group
NO INTERVENTIONControl group using a hemodynamic standard protocol
Photoplethysmography group
OTHERHemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)
Interventions
Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period
Eligibility Criteria
You may qualify if:
- Age\> 18 years
- Colorectal surgery
You may not qualify if:
- Pregnant women
- Black skin
- Chronic renal insufficiency (MDRD \<30 ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen University Hospital
Caen, 14 000, France
Related Publications (1)
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.
PMID: 27004412RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Lise Fiant, MD
University Hospital of Caen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2014
First Posted
January 22, 2015
Study Start
December 1, 2014
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
April 2, 2026
Record last verified: 2019-05