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 > WoMan trial
 

 

WoMan trial

 

WOrd catheter or MArsupialisation in treatment of cyst or abscess of the bartholin gland.

 

Go to the WoMan website.

 

Problem:

Cysts or abscesses 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.

 

Objective:

To study the effectiveness of these treatment options and consider recurrence, cost effectivenss en patient preferences.

 

Study design:

Multicenter randomized controlled trial.

 

Study population:

Patients with an abscess or cyst of the Bartholin gland, who require treatment.

 

Intervention:

Patients will be randomized for treatment by marsupialization or by placing of a Word catheter.

 

Primary study parameters:

Recurrence of the abscess or cyst of the Bartholin gland.

 

Power/ Data Analyses

We anticipate that a recurrence rate of 5% will outweigh the differences of both treatments and additional costs. Under these assumptions we will randomise 160 women ( two groups of 80)


Economic Evaluation:

As we expect lower total costs in the Word catheter group, the economic analysis will be a cost-effectiveness analysis.

Time Schedule:
Total study time 12 months.

Projectleaders:
Prof. Dr. B.W. J. Mol, AMC, Amsterdam

Dr. L.P. Morssink, , MCL, Leeuwarden

Dr. N.Reeskink, , MCL Leeuwarden

Dr. J.P.W.R. Roovers, , AMC Amsterdam