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

University Hospital, Caen1 site in 1 country160 target enrollmentDecember 2014

ConditionsPolyp of Large Intestine Colorectal Neoplasms Crohn Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Polyp of Large Intestine
Sponsor: University Hospital, Caen
Enrollment: 160
Locations: 1
Primary Endpoint: Incidence of patients presenting at least one complication after colorectal surgery
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

December 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Caen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age\> 18 years
•Colorectal surgery

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

Perioperative mortality(28 days after surgery)
Real length of hospital stay(Up to 28 days after surgery (length of hospital stay))
All complications happening after colorectal surgery(Up to 28 days after surgery (length of hospital stay))