Clinical trial NCT04093310: Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
Official title: Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bartholin's Gland Abscess Treatment
Keywords: incision-drainage
Bartholin's abscess
Word catheter
Marsupialization
Cost-utility analysis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 302
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: cost-utility ratio, according to the societal perspective of the of the management of Bartholin's gland abscess by the Word catheter compared to the incision-drainage
timeFrame: 12 months
Secondary outcomes:
measure: Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter
timeFrame: 5 years
measure: Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain
timeFrame: at baseline and day 1
measure: Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate
timeFrame: 12 months
measure: Comparison of Word catheter versus incision-drainage concerning pain
timeFrame: 12 months
measure: Comparison of Word catheter versus incision-drainage concerning management time
timeFrame: Day 0 (procedure day), Day 1
measure: Comparison of Word catheter versus incision-drainage in terms of complications
timeFrame: 12 months
measure: Comparison of Word catheter versus incision-drainage in terms of surgical failure
timeFrame: Immediate post-operative (D0) and one month
measure: Comparison of Word catheter versus incision-drainage in terms of impact on sexual activity
timeFrame: Baseline, one month, 6 months and 12 months
measure: Comparison of Word catheter versus incision-drainage in terms of quality of life using the SF-12-HS
timeFrame: Baseline, one month, 6 months and 12 months
measure: Comparison of Word catheter versus incision-drainage in terms of quality of life using the EQ-5D
timeFrame: Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months
measure: Comparison of Word catheter versus incision-drainage in terms global patient impression and improvement
timeFrame: One day, one month, 3 months, 6 months, 9 months and 12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Caen
country: France
facility: CHU CAEN
city: Clamart
country: France
facility: Ch Antoine Beclere
city: Clermont-Ferrand
country: France
facility: Chu Estaing
city: Levallois-Perret
country: France
facility: Institut Franco Britannique
city: Lille
country: France
facility: Chu Lille
city: Nancy
country: France
facility: Nancy University Hospital
city: Nantes
country: France
facility: Chu Nantes
city: Nîmes
country: France
facility: Chu Caremeau
city: Paris
country: France
facility: Ch Kremlin Bicetre
city: Paris
country: France
facility: Chu Cochin
city: Paris
country: France
facility: Chu Robert Debre
city: Poissy
country: France
facility: Chi Poissy
city: Poitiers
country: France
facility: Chu Poitiers
city: Rennes
country: France
facility: Rennes University Hospital
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Thibault Thubert, PhD
role: PRINCIPAL_INVESTIGATOR
References: