Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.

NCT ID: NCT04093310

Last Updated: 2023-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-17

Study Completion Date

2024-05-31

Brief Summary

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Bartholin's gland abscess is a condition requiring emergency consultation. Placement of a Word catheter, which is a minor technique used in France as a treatment of bartholin's Abscess, can be done in an emergency room without hospitalization. Actually, incision-drainage, which is the most widespread treatment in France, is performed on day surgery with or without overnight hospitalization. Our hypothesis is that the use of Word catheter compared to incision-drainage would not modify the quality of life of the patients but would allow a saving of up to 3 M€ per year in France.

Detailed Description

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Conditions

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Bartholin's Gland Abscess Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Word catheter

The abscess is incised and the Word catheter is inserted into the residual cavity to create a neo-channel to prevent recurrence. The catheter is removed after 4 weeks during a consultation

Group Type EXPERIMENTAL

Word Catheter

Intervention Type DEVICE

Use of the Word catheter to remove the Bartholin's abscess

Incision-drainage

This procedure performed under general or loco-regional anaesthesia consists in incising the abscess, draining the pus build-up and placing a wick in the residual cavity to promote progressive healing from the inside out.

Group Type ACTIVE_COMPARATOR

Incision-drainage

Intervention Type PROCEDURE

Incision-drainage to remove the Bartholin's abscess

Interventions

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Word Catheter

Use of the Word catheter to remove the Bartholin's abscess

Intervention Type DEVICE

Incision-drainage

Incision-drainage to remove the Bartholin's abscess

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed informed consent Patient with social insurance

Exclusion Criteria

Spontaneous fistulization of the abscess before surgical treatment Abscess volume under 3 ml Medical treatment which avoid incision or word catheter placement patients under guardianship Unable to complete questionnaires Patients not affiliated to social protection regimen Pregnant or post-partum women (until 4 weeks after delivery)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thibault Thubert, PhD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Chu Angers

Angers, , France

Site Status

Bordeaux University Hospital

Bordeaux, , France

Site Status

CHU CAEN

Caen, , France

Site Status

Ch Antoine Beclere

Clamart, , France

Site Status

Chu Estaing

Clermont-Ferrand, , France

Site Status

Institut Franco Britannique

Levallois-Perret, , France

Site Status

Chu Lille

Lille, , France

Site Status

Nancy University Hospital

Nancy, , France

Site Status

Chu Nantes

Nantes, , France

Site Status

Chu Caremeau

Nîmes, , France

Site Status

Ch Kremlin Bicetre

Paris, , France

Site Status

Chu Cochin

Paris, , France

Site Status

Chu Robert Debre

Paris, , France

Site Status

Chi Poissy

Poissy, , France

Site Status

Chu Poitiers

Poitiers, , France

Site Status

Rennes University Hospital

Rennes, , France

Site Status

Chu Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC19_0179

Identifier Type: -

Identifier Source: org_study_id

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