Marsupialization and placement of a word catheter for the management of the cyst or abscess of the bartholin gland will be studied. Medical effectiveness in terms of recurrence of the cyst or abscess after 1 year follow up will be evaluated. Patient…
ID
Source
Brief title
Condition
- Female reproductive tract infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recurrence rate of cysts or abscess of the bartholin gland 1 year after
treatment.
Secondary outcome
Which treatment option (marsupialization or word catheter) is preferred by the
patient?
Which treatment option (marsupialization or word catheter) gives the least pain
during and after the procedure?
Background summary
Cysts or abcesses of the bartholin gland are common problems in women of
reproductive age. They can cause pain and limitation of activity. Various
treatment options are used to resolve the problem. The objective of these
procedures is to drain the cyst or abscess and create a permanent outflow tract
to prevent the recurrence of the cyst or abscess. Marsupialization and
placement of a word catheter are commonly used methods in the Netherlands. It
is unclear which treatment option gives the least relapses and the most patient
satisfaction. The present proposal will study the effects of these treatment
options. The proposal will consider recurrence, post operative pain and patient
preferences.
Study objective
Marsupialization and placement of a word catheter for the management of the
cyst or abscess of the bartholin gland will be studied. Medical effectiveness
in terms of recurrence of the cyst or abscess after 1 year follow up will be
evaluated. Patient statisfaction and postoperative pain will also be evaluated.
We will answer the following questions:
1. Which treatment option (Marsupialization or Word catheter) gives the least
recurrences of the cyst or abscess of the bartholin gland after 1 year follow
up?
2. Which treatment option(Marsupialization or Word catheter) is preferred by
the patients?
3, Which option (Marsupialization or Word catheter) gives the least
postoperative pain?
Study design
Multicenter randomized controlled trial.
Intervention
Patients will be randomized for treatment by marsupialization or by placement
of a word catheter.
Study burden and risks
Depending on the complaints caused by the cyst or abscess of the bartholin
gland patients will undergo treatment as soon as possible.
Both treatment options are often practiced in all hospitals in the Netherlands.
During the follow up of one year patients will receive a questionnaire by
e-mail to asess their pain 1 day, 1 week and 3 months after the treatment.
After one year all patients receive a questionnaire to assess patient
preferences.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients visiting the outpatient clinic with a symptomatic cyst or abscess of the bartholin gland, which requires surgical treatment at the moment.
Exclusion criteria
- patients who don't give their informed consent
- patients with contraindications for one of the procedures at the time of randomization ( for example: patients with contraindication for general anesthaesia)
- patients who do not master dutch or english language
- Patients who are younger than 18 years of age and mentally competent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30532.018.10 |