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

Primary Purpose

Bartholin's Gland Abscess Treatment

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Word Catheter
Incision-drainage
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bartholin's Gland Abscess Treatment focused on measuring incision-drainage, Bartholin's abscess, Word catheter, Marsupialization, Cost-utility analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Chu Angers
  • Bordeaux University Hospital
  • CHU CAEN
  • Ch Antoine Beclere
  • Chu Estaing
  • Institut Franco Britannique
  • Chu Lille
  • Nancy University Hospital
  • Chu Nantes
  • Chu Caremeau
  • Ch Kremlin Bicetre
  • Chu Cochin
  • Chu Robert Debre
  • Chi Poissy
  • Chu Poitiers
  • Rennes University Hospital
  • Chu Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Word catheter

Incision-drainage

Arm Description

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

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.

Outcomes

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
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
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
Pain numeric scale from 0 to 10
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
Comparison of Word catheter versus incision-drainage concerning pain
Pain numeric scale from 0 to 10
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
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
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
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
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
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)
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

Full Information

First Posted
September 16, 2019
Last Updated
June 5, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04093310
Brief Title
Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
Acronym
BARTHO-KT
Official Title
Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bartholin's Gland Abscess Treatment
Keywords
incision-drainage, Bartholin's abscess, Word catheter, Marsupialization, Cost-utility analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Word catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Incision-drainage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Word Catheter
Intervention Description
Use of the Word catheter to remove the Bartholin's abscess
Intervention Type
Procedure
Intervention Name(s)
Incision-drainage
Intervention Description
Incision-drainage to remove the Bartholin's abscess
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Budget impact analysis for the health insurance point of view in case of diffusion of the Word catheter
Description
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
Title
Non inferiority evaluation of Word catheter vs. Incision drainage in terms of pain
Description
Pain numeric scale from 0 to 10
Time Frame
at baseline and day 1
Title
Non inferiority evaluation of Word catheter versus incision-drainage in terms of recurrence rate
Description
Number of homolateral recurrences of Bartholin's abscess, declared by the patient
Time Frame
12 months
Title
Comparison of Word catheter versus incision-drainage concerning pain
Description
Pain numeric scale from 0 to 10
Time Frame
12 months
Title
Comparison of Word catheter versus incision-drainage concerning management time
Description
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
Title
Comparison of Word catheter versus incision-drainage in terms of complications
Description
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
Title
Comparison of Word catheter versus incision-drainage in terms of surgical failure
Description
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
Title
Comparison of Word catheter versus incision-drainage in terms of impact on sexual activity
Description
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
Title
Comparison of Word catheter versus incision-drainage in terms of quality of life using the SF-12-HS
Description
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
Title
Comparison of Word catheter versus incision-drainage in terms of quality of life using the EQ-5D
Description
EQ-5D 5L score (described in primary outcome)
Time Frame
Baseline, one day, one month, 3 months, 6 months, 9 months and 12 months
Title
Comparison of Word catheter versus incision-drainage in terms global patient impression and improvement
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibault Thubert, PhD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Angers
City
Angers
Country
France
Facility Name
Bordeaux University Hospital
City
Bordeaux
Country
France
Facility Name
CHU CAEN
City
Caen
Country
France
Facility Name
Ch Antoine Beclere
City
Clamart
Country
France
Facility Name
Chu Estaing
City
Clermont-Ferrand
Country
France
Facility Name
Institut Franco Britannique
City
Levallois-Perret
Country
France
Facility Name
Chu Lille
City
Lille
Country
France
Facility Name
Nancy University Hospital
City
Nancy
Country
France
Facility Name
Chu Nantes
City
Nantes
Country
France
Facility Name
Chu Caremeau
City
Nîmes
Country
France
Facility Name
Ch Kremlin Bicetre
City
Paris
Country
France
Facility Name
Chu Cochin
City
Paris
Country
France
Facility Name
Chu Robert Debre
City
Paris
Country
France
Facility Name
Chi Poissy
City
Poissy
Country
France
Facility Name
Chu Poitiers
City
Poitiers
Country
France
Facility Name
Rennes University Hospital
City
Rennes
Country
France
Facility Name
Chu Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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