Bartholin's Gland Abscess Treatment
Conditions
Keywords
incision-drainage, Bartholin's abscess, Word catheter, Marsupialization, Cost-utility analysis
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.
Interventions
DEVICEWord Catheter
Use of the Word catheter to remove the Bartholin's abscess
PROCEDUREIncision-drainage
Incision-drainage to remove the Bartholin's abscess
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 complications | 12 months | number of complications related to the procedure (healing complications, infection, lost of the Word catheter), contro-lateral Bartholin's abscess occurrence |
| 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 |
| 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 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 |
| 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 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 |
| 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 |
Countries
France
Outcome results
None listed