Bartholin's Gland Abscess Treatment Clinical Trial
— BARTHO-KTOfficial title:
Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
| Verified date | June 2023 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 302 |
| Est. completion date | May 31, 2024 |
| Est. primary completion date | May 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | Ch Kremlin Bicetre | Paris | |
| France | Chu Cochin | Paris | |
| France | Chu Robert Debre | Paris | |
| France | Chi Poissy | Poissy | |
| France | Chu Poitiers | Poitiers | |
| France | Rennes University Hospital | Rennes | |
| France | Chu Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
12 months | |
| Secondary | 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 | 5 years | |
| Secondary | Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain | Pain numeric scale from 0 to 10 | at baseline and day 1 | |
| Secondary | 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 | 12 months | |
| Secondary | Comparison of Word catheter versus incision-drainage concerning pain | Pain numeric scale from 0 to 10 | 12 months | |
| Secondary | 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 | Day 0 (procedure day), Day 1 | |
| Secondary | 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 | 12 months | |
| Secondary | 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 | Immediate post-operative (D0) and one month | |
| Secondary | 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 | Baseline, one month, 6 months and 12 months | |
| Secondary | 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 | Baseline, one month, 6 months and 12 months | |
| Secondary | 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) | Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months | |
| Secondary | 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 | One day, one month, 3 months, 6 months, 9 months and 12 months |