Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery

Phase 3

Completed

• Conditions: Polyp of Large Intestine; Crohn Disease; Colorectal Neoplasms
• Interventions: Device: Photoplethysmography

• Registration Number: NCT02343601
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-06-13
• Study Start: 2014-12
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age> 18 years
• Colorectal surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photoplethysmography group	Photoplethysmography	Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)

Primary Outcome Measures

Name	Time	Method
Incidence of patients presenting at least one complication after colorectal surgery	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

Name	Time	Method
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)

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France