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

Nantes University Hospital302 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

302

Conditions

Bartholin's Gland Abscess Treatment

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (17)

Chu Angers

Angers, France

Bordeaux University Hospital

Bordeaux, France

CHU CAEN

Caen, France

Ch Antoine Beclere

Clamart, France

Chu Estaing

Clermont-Ferrand, France

Institut Franco Britannique

Levallois-Perret, France

Chu Lille

Lille, France

Nancy University Hospital

Nancy, France

Chu Nantes

Nantes, France

Chu Caremeau

Nîmes, France

...and 7 more locations

Outcomes

Primary Outcomes

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

The utility will be measured by: Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible. The costs will be measured by the addition of the following costs: Outpatient resource consumption collected in a declarative patient questionnaire. Hospital care resources using the the database of the Medicalised Information System Program of each recruiting site

Time frame: 12 months

Secondary Outcomes

Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter

Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives

Time frame: 5 years

Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain

Pain numeric scale from 0 to 10

Time frame: at baseline and day 1

Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate

Number of homolateral recurrences of Bartholin's abscess, declared by the patient

Time frame: 12 months

Comparison of Word catheter versus incision-drainage concerning pain

Pain numeric scale from 0 to 10

Time frame: 12 months

Comparison of Word catheter versus incision-drainage concerning management time

Date and time of patient initial management (randomization) Date and time of the beginning of the procedure date and time of the end of the procedure date and time of the hospital departure

Time frame: Day 0 (procedure day), Day 1

Comparison of Word catheter versus incision-drainage in terms of complications

number of complications related to the procedure (healing complications, infection, lost of the Word catheter), contro-lateral Bartholin's abscess occurrence

Time frame: 12 months

Comparison of Word catheter versus incision-drainage in terms of surgical failure

Word catheter: insertion failure, loss, removal decision (from the patient or the surgeon) Incision-drainage: incomplete drainage

Time frame: Immediate post-operative (D0) and one month

Comparison of Word catheter versus incision-drainage in terms of impact on sexual activity

Score of the Female Sexual Function Index: self-questionnaire including 19 questions assessing different parameters of the sexual activity

Time frame: Baseline, one month, 6 months and 12 months

Comparison of Word catheter versus incision-drainage in terms of quality of life using the SF-12-HS

Short-Form-12-Health-Survey questionnaire score: self-questionnaire including 12 questions measuring different aspects of quality of life

Time frame: Baseline, one month, 6 months and 12 months

Comparison of Word catheter versus incision-drainage in terms of quality of life using the EQ-5D

EQ-5D 5L score (described in primary outcome)

Time frame: Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months

Comparison of Word catheter versus incision-drainage in terms global patient impression and improvement

Patient Global Impression and Improvement (PGI-I) global index used to rate the response of a condition to a therapy (transition scale). It is a single question asking the patient to rate their global condition now, as compared with how it was prior to before beginning treatment on a scale from 1 - very much better to 7 - very much worse

Time frame: One day, one month, 3 months, 6 months, 9 months and 12 months