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Management of Bartholin gland cyst and abscess: marsupialization or word catheter.


- candidate number8029
- NTR NumberNTR2305
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2010
- Secondary IDs09/318 METC Academical Medical Center, Amsterdam
- Public TitleManagement of Bartholin gland cyst and abscess: marsupialization or word catheter.
- Scientific TitleManagement of Bartholin gland cyst and abscess: marsupialization or word catheter.
- ACRONYMWoMan
- hypothesisIs there a difference in the recurrence rate if you treat a cyst or abscess of the bartholin gland with a marsupialization or placement of a word catheter.
- Healt Condition(s) or Problem(s) studiedBartholin gland cyst, Marsupialization, Word catheter
- Inclusion criteriaPatients visiting the outpatient clinic with a symptomatic cyst or abscess of the Bartholin gland, which requires surgical treatment at that moment.
- Exclusion criteria1. Patients who don't give informed consent;
2. Patient with contra indications for one of the procedures at the time of randomization;
3. Patients who do not master english or dutch language;
4. Patients younger than 18 years or mentally competent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mei-2012
- Target number of participants160
- Interventions1. Placement of Word catheter;
2. Marsupialization.
- Primary outcomeRecurrence rate after one year.
- Secondary outcomeWhich treatment option (marsupialization or word catheter) gives the leats pain during and after the procedure.
- TimepointsFollow-up is one year.
- Trial web sitewww.studies-obsgyn.nl/woman/
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES P.A.L. Kop
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryCysts or abcesses of the bartholin gland are commly treated with placement of a word catheter or marsupialization. In this multcenter randomised trial we study the effectiveness of these treatment options and consider recurrence of the cyst or abscess within one year and pain.
- Main changes (audit trail)
- RECORD28-apr-2010 - 25-nov-2016


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