Bartholin's Gland Abscess TreatmentBARTHO-KTNCT04093310
Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
A study testing Word Catheter and Incision-drainage in people with Bartholin's Gland Abscess Treatment, run by Nantes University Hospital at 17 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bartholin's Gland Abscess Treatment
- What is being tested?
- Word Catheter and Incision-drainage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 17 sitesFrance
- Study dates
- 17 Jan 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed informed consent Patient with social insurance
Who cannot join
- 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)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Chu Angers
Angers
Bordeaux University Hospital
Bordeaux
CHU CAEN
Caen
Ch Antoine Beclere
Clamart
Chu Estaing
Clermont-Ferrand
Institut Franco Britannique
Levallois-Perret
Chu Lille
Lille
Nancy University Hospital
Nancy
Chu Nantes
Nantes
Chu Caremeau
Nîmes
Ch Kremlin Bicetre
Paris
Chu Cochin
Paris
Chu Robert Debre
Paris
Chi Poissy
Poissy
Chu Poitiers
Poitiers
Rennes University Hospital
Rennes
Chu Toulouse
Toulouse
About this study
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.
- Conditions
- Bartholin's Gland Abscess Treatment
- Being tested
- Word Catheter, Incision-drainage
- Keywords
- incision-drainage, Bartholin's abscess, Word catheter, Marsupialization, Cost-utility analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Word CatheterDevice
Use of the Word catheter to remove the Bartholin's abscess
Incision-drainageProcedure or surgery
Incision-drainage to remove the Bartholin's abscess
| Study group | Role | What they receive |
|---|---|---|
| Word catheter | Experimental | 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 Receives: Device: Word Catheter |
| Incision-drainage | Active comparator | 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. Receives: Procedure: Incision-drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (11)
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
Measured: 5 years
Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain
Pain numeric scale from 0 to 10
Measured: 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
Measured: 12 months
Comparison of Word catheter versus incision-drainage concerning pain
Pain numeric scale from 0 to 10
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: One day, one month, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start17 Jan 2020
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bartholin's Gland Abscess TreatmentStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault Thubert, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093310
- Sponsor's protocol ID
- RC19_0179
- Acronym
- BARTHO-KT
- Status last verified
- Jun 2023
- First submitted
- 16 Sep 2019
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
- ClinicalTrials.gov ID
- NCT04093310
- Acronym / sponsor ID
- BARTHO-KT / RC19_0179
- Conditions
- Bartholin's Gland Abscess Treatment
- Keywords
- incision-drainage, Bartholin's abscess, Word catheter, Marsupialization, Cost-utility analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Word catheter | Experimental | Device: Word CatheterThe 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 | Active comparator | Procedure: Incision-drainageThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed informed consent Patient with social insurance
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Word CatheterUse of the Word catheter to remove the Bartholin's abscess | Device | Word catheter |
| Incision-drainageIncision-drainage to remove the Bartholin's abscess | Procedure or surgery | Incision-drainage |
Primary outcome
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
Time frame: 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
11 secondary outcomes
Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter
Time frame: 5 years
Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain
Time frame: at baseline and day 1
Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate
Time frame: 12 months
Comparison of Word catheter versus incision-drainage concerning pain
Time frame: 12 months
Comparison of Word catheter versus incision-drainage concerning management time
Time frame: Day 0 (procedure day), Day 1
Comparison of Word catheter versus incision-drainage in terms of complications
Time frame: 12 months
Comparison of Word catheter versus incision-drainage in terms of surgical failure
Time frame: Immediate post-operative (D0) and one month
Comparison of Word catheter versus incision-drainage in terms of impact on 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
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
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
Time frame: One day, one month, 3 months, 6 months, 9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibault Thubert, PhD principal investigator
Nantes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Word Catheter and Incision-drainage in people with Bartholin's Gland Abscess Treatment, run by Nantes University Hospital at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.