Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

Crohn Disease Clinical Trial

— PANEX3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343601
• Other study ID #: 2014-A00870-47
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Age> 18 years

• Colorectal surgery

Exclusion Criteria:

• Pregnant women

• Black skin

• Chronic renal insufficiency (MDRD <30 ml/min)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Crohn Disease
• Polyp of Large Intestine

Intervention

Device:
• Photoplethysmography
Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 28 days after surgery (length of hospital stay)
Primary	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	All complications happening after colorectal surgery		Up to 28 days after surgery (length of hospital stay)
Secondary	Real length of hospital stay		Up to 28 days after surgery (length of hospital stay)
Secondary	Perioperative mortality		28 days after surgery