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Trial record 1 of 1 for:    NCT02343601
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Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery (PANEX3)

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ClinicalTrials.gov Identifier: NCT02343601
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Polyp of Large Intestine Colorectal Neoplasms Crohn Disease Device: Photoplethysmography Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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 Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age> 18 years
  • Colorectal surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343601


Locations
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France
Caen University Hospital
Caen, France, 14 000
Sponsors and Collaborators
University Hospital, Caen
Investigators
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Principal Investigator: Anne-Lise Fiant, MD University Hospital of Caen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02343601    
Other Study ID Numbers: 2014-A00870-47
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Rectal Diseases