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

Nantes University Hospital (NUH)

Status: Active, not recruiting

Conditions: Bartholin's Gland Abscess Treatment

Treatments: Procedure: Incision-drainage; Device: Word Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04093310

RC19_0179

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Word catheter

Experimental group

Description:

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

Treatment:

Device: Word Catheter

Incision-drainage

Active Comparator group

Description:

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.

Treatment:

Procedure: Incision-drainage