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

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 Overview

• Status: Active, not recruiting
• Conditions: Bartholin's Gland Abscess Treatment
• Intervention / Treatment: Device: Word Catheter; Procedure: Incision-drainage

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Chu Angers
  • Bordeaux, France
    • Bordeaux University Hospital
  • Caen, France
    • CHU Caen
  • Clamart, France
    • Ch Antoine Beclere
  • Clermont-Ferrand, France
    • CHU Estaing
  • Levallois-Perret, France
    • Institut Franco Britannique
  • Lille, France
    • Chu Lille
  • Nancy, France
    • Nancy University Hospital
  • Nantes, France
    • Chu Nantes
  • Nîmes, France
    • CHU Caremeau
  • Paris, France
    • CHU Cochin
  • Paris, France
    • CHU Robert Debré
  • Paris, France
    • Ch Kremlin Bicetre
  • Poissy, France
    • Chi Poissy
  • Poitiers, France
    • CHU Poitiers
  • Rennes, France
    • Rennes University Hospital
  • Toulouse, France
    • Chu Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Comparison of Word catheter versus incision-drainage concerning pain	Pain numeric scale from 0 to 10	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	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	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	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	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	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)	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	One day, one month, 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Thibault Thubert, PhD, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2020
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Cost-utility analysis; incision-drainage; Bartholin's abscess; Word catheter; Marsupialization
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess
• Other Study ID Numbers: RC19_0179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No