An interventional study of Word Catheter and Incision-drainage in Bartholin's Gland Abscess Treatment, sponsored by Nantes University Hospital. Active, not recruiting at 17 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
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.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
This study's enrollment of 302 is above the median of 110 across 120 interventional studies indexed under Abscess.
Browse Abscess studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Abscess of Bartholin's gland Patient able to understand the protocol Patient who signed 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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Word Catheter
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.
Procedure: Incision-drainage
Use of the Word catheter to remove the Bartholin's abscess
Incision-drainage to remove the Bartholin's abscess
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
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
Started Jan 2020 (actual). Primary completion is estimated for May 2024, 52 months after the start.
Of 21 interventional studies with no phase under Abscess, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's planned 52 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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