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

Centre Hospitalier Universitaire de Besancon571 enrolled

Overview

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 .

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

571

Conditions

Otorhinolaryngologic Diseases

Interventions

SurgifloDEVICE

using device during the endonasal surgery.

FlosealDEVICE

using device during the endonasal surgery.

AlgosterilDEVICE

using device during the endonasal surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Per-operative hemostasis

Time needs to observe hemostasis after the device set up

Time frame: Hours 0

Hemostasis in the 6 first hours

Number of compresses used from Hours 0 to Hours 6.

Time frame: 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.

Time frame: Hours 24

Spontaneous hemorrhagic events

number of spontaneous hemorrhagic events.

Time frame: from Hours 0 to Day 45

Secondary Outcomes

Preoperative assessment

Preoperative scanner assessment with Lund ans Mackay score

Time frame: Before the endonasal surgery

Preoperative assessment

Laboratory tests of hemostasis (platelets, fibrinogen...)

Time frame: Hours 0

Device evaluation by the surgeon

time needs to set up the device

Time frame: Hours 0

Device evaluation by the surgeon

subjective assessment of the implementation ease

Time frame: Hours 0

Data from ClinicalTrials.gov

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