BARTHO-KT: Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04093310

Collaborator

(none)

302

Enrollment

Locations

Arms

50.4

Anticipated Duration (Months)

17.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bartholin's Gland Abscess Treatment	Device: Word Catheter Procedure: Incision-drainage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

302 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.

Actual Study Start Date :

Jan 17, 2020

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: Word Catheter Use of the Word catheter to remove the Bartholin's abscess
Active Comparator: 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.	Procedure: Incision-drainage Incision-drainage to remove the Bartholin's abscess

Arm

Intervention/Treatment

Experimental: 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

Device: Word Catheter

Use of the Word catheter to remove the Bartholin's abscess

Active Comparator: 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.

Procedure: Incision-drainage

Incision-drainage to remove the Bartholin's abscess

Outcome Measures

Primary Outcome Measures

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

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
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
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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	Chu Angers	Angers	France
2	Bordeaux University Hospital	Bordeaux	France
3	CHU CAEN	Caen	France
4	Ch Antoine Beclere	Clamart	France
5	Chu Estaing	Clermont-Ferrand	France
6	Institut Franco Britannique	Levallois-Perret	France
7	Chu Lille	Lille	France
8	Nancy University Hospital	Nancy	France
9	Chu Nantes	Nantes	France
10	Chu Caremeau	Nîmes	France
11	Ch Kremlin Bicetre	Paris	France
12	Chu Cochin	Paris	France
13	Chu Robert Debre	Paris	France
14	Chi Poissy	Poissy	France
15	Chu Poitiers	Poitiers	France
16	Rennes University Hospital	Rennes	France
17	Chu Toulouse	Toulouse	France