Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery (PRHEPOCE)

Randomized Medico-economic Assessment of Preventive Devices Used for Post-operative Hemorrhagic Risk in Endonasal Surgery

This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .

Study Overview

• Status: Completed
• Conditions: Otorhinolaryngologic Diseases
• Intervention / Treatment: Device: Surgiflo; Device: Floseal; Device: Algosteril

Detailed Description

Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery.

Floseal® is a haemostatic frost(gel) containing of the thrombin.

Algosteril® is a lint tent of arginate of calcium.

• Study Type: Interventional
• Enrollment (Actual): 571
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• endonasal surgery schedule
• Surgical indications:

hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,

Exclusion Criteria:

• Pregnant Woman
• Disorder of the haemostasis known or disrupted preoperative biological balance assessment
• Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
• Unchecked HTA by the treatment and/or preoperative > mmHg 160/90
• Surgical Act including a septoplasty
• malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system
• Dacryocystorhinostomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgiflo; Using Surgiflo® (Absorbable Gelatin Hemostatic) for the post-operative haemostasis in endonasal surgery.	Device: Surgiflo; using device during the endonasal surgery.
Experimental: Floseal; Using Floseal® (Absorbable Gelatin Hemostatic) containing human thrombin for the post-operative haemostasis in endonasal surgery	Device: Floseal; using device during the endonasal surgery.
Experimental: Algosteril; Using Algosteril® (Hemostatic Sterile Wick) for the post-operative haemostasis in endonasal surgery	Device: Algosteril; using device during the endonasal surgery.
No Intervention: Abstention; Not using device for the post-operative haemostasis in endonasal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per-operative hemostasis	Time needs to observe hemostasis after the device set up	Hours 0
Hemostasis in the 6 first hours	Number of compresses used from Hours 0 to Hours 6.	Hours 6
Hemostasis at the 24th hour	Algosteril arm (after having removed the wick): spontaneous observation of hemostasis in less that 3 min (yes/no) and needs to have a new intervention to stop bleedings (type); Surgiflo, Floseal, Abstention arms: time to observe hemostasis if bleedings occurred.	Hours 24
Spontaneous hemorrhagic events	number of spontaneous hemorrhagic events.	from Hours 0 to Day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative assessment	Preoperative scanner assessment with Lund ans Mackay score	Before the endonasal surgery
Preoperative assessment	Laboratory tests of hemostasis (platelets, fibrinogen...)	Hours 0
Device evaluation by the surgeon	time needs to set up the device	Hours 0
Device evaluation by the surgeon	subjective assessment of the implementation ease	Hours 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Laurent TAVERNIER, PH, Chu Besancon

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 4, 2017
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Hemostatics; Coagulants; Surgiflo
• Other Study ID Numbers: SHC/2009/001/P