Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
- Conditions
- Bartholin's Gland Abscess Treatment
- Interventions
- Device: Word CatheterProcedure: Incision-drainage
- Registration Number
- NCT04093310
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 302
Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed informed consent Patient with social insurance
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Word catheter 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 Incision-drainage 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.
- Primary Outcome Measures
Name Time Method 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 12 months 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
- Secondary Outcome Measures
Name Time Method Comparison of Word catheter versus incision-drainage in terms of complications 12 months number of complications related to the procedure (healing complications, infection, lost of the Word catheter), contro-lateral Bartholin's abscess occurrence
Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate 12 months Number of homolateral recurrences of Bartholin's abscess, declared by the patient
Comparison of Word catheter versus incision-drainage concerning pain 12 months Pain numeric scale from 0 to 10
Comparison of Word catheter versus incision-drainage concerning management time Day 0 (procedure day), Day 1 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
Comparison of Word catheter versus incision-drainage in terms of surgical failure Immediate post-operative (D0) and one month Word catheter: insertion failure, loss, removal decision (from the patient or the surgeon) Incision-drainage: incomplete drainage
Comparison of Word catheter versus incision-drainage in terms of impact on sexual activity Baseline, one month, 6 months and 12 months Score of the Female Sexual Function Index: self-questionnaire including 19 questions assessing different parameters of the sexual activity
Comparison of Word catheter versus incision-drainage in terms global patient impression and improvement One day, one month, 3 months, 6 months, 9 months and 12 months 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
Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter 5 years Comparison of intervention costs on the study sample and projection of these costs over 5 years, from the health insurance and hospital perspectives
Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain at baseline and day 1 Pain numeric scale from 0 to 10
Comparison of Word catheter versus incision-drainage in terms of quality of life using the EQ-5D Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months EQ-5D 5L score (described in primary outcome)
Comparison of Word catheter versus incision-drainage in terms of quality of life using the SF-12-HS Baseline, one month, 6 months and 12 months Short-Form-12-Health-Survey questionnaire score: self-questionnaire including 12 questions measuring different aspects of quality of life
Trial Locations
- Locations (17)
CHU CAEN
🇫🇷Caen, France
Chu Angers
🇫🇷Angers, France
Bordeaux University Hospital
🇫🇷Bordeaux, France
Chu Estaing
🇫🇷Clermont-Ferrand, France
Institut Franco Britannique
🇫🇷Levallois-Perret, France
Chu Nantes
🇫🇷Nantes, France
Chu Caremeau
🇫🇷Nîmes, France
Ch Kremlin Bicetre
🇫🇷Paris, France
Chu Cochin
🇫🇷Paris, France
Chi Poissy
🇫🇷Poissy, France
Chu Poitiers
🇫🇷Poitiers, France
Rennes University Hospital
🇫🇷Rennes, France
Ch Antoine Beclere
🇫🇷Clamart, France
Chu Lille
🇫🇷Lille, France
Nancy University Hospital
🇫🇷Nancy, France
Chu Robert Debre
🇫🇷Paris, France
Chu Toulouse
🇫🇷Toulouse, France