Back to resultsPerioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery (PANEX3)
Primary Purpose
Polyp of Large Intestine, Colorectal Neoplasms, Crohn Disease
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Photoplethysmography
Sponsored by
About this trial
This is an interventional other trial for Polyp of Large Intestine
Eligibility Criteria
Inclusion Criteria:
- Age> 18 years
- Colorectal surgery
Exclusion Criteria:
- Pregnant women
- Black skin
- Chronic renal insufficiency (MDRD <30 ml/min)
Sites / Locations
- Caen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Control group
Photoplethysmography group
Arm Description
Control group using a hemodynamic standard protocol
Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)
Outcomes
Primary Outcome Measures
Incidence of patients presenting at least one complication after colorectal surgery
Two independent experts defined the presence of complication using an a priori classification.
Secondary Outcome Measures
All complications happening after colorectal surgery
Real length of hospital stay
Perioperative mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02343601
Brief Title
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery
Acronym
PANEX3
Official Title
Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Large Intestine, Colorectal Neoplasms, Crohn Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group using a hemodynamic standard protocol
Arm Title
Photoplethysmography group
Arm Type
Other
Arm Description
Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)
Intervention Type
Device
Intervention Name(s)
Photoplethysmography
Intervention Description
Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period
Primary Outcome Measure Information:
Title
Incidence of patients presenting at least one complication after colorectal surgery
Description
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 Outcome Measure Information:
Title
All complications happening after colorectal surgery
Time Frame
Up to 28 days after surgery (length of hospital stay)
Title
Real length of hospital stay
Time Frame
Up to 28 days after surgery (length of hospital stay)
Title
Perioperative mortality
Time Frame
28 days after surgery
Other Pre-specified Outcome Measures:
Title
Medico economic evaluation of cost of treatment
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> 18 years
Colorectal surgery
Exclusion Criteria:
Pregnant women
Black skin
Chronic renal insufficiency (MDRD <30 ml/min)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Lise Fiant, MD
Organizational Affiliation
University Hospital of Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14 000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27004412
Citation
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.
Results Reference
derived
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Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery
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