Morcellation and Uterine Snare Resection Trial

Endometrial polyps occur in both pre- and postmenopausal women and are often
asymptomatic. When symptoms occur they
most commonly include abnormal uterine bleeding. The vast majority of polyps
are benign with a prevalence of atypia and
malignancy of 0.8% and 3.1% respectively.
The first choice treatment for endometrial polyps is hysteroscopic resection.
The miniaturisation of hysteroscopes and ancillary
instrumentation coupled with enhanced visualisation has enabled hysteroscopic
surgery to be performed in an outpatient
setting without the need for general anaesthesia.
The removal of endometrial polyps with the Duckbill snare as an office
procedure has first been described in 2005. Whilst the
technology is feasible and effective it requires skills and experience in
outpatient hysteroscopic surgery, which many
gynecologists lack and this is reflected in the limited adoption of polyp snare
procedures. The limited adoption can additionally
be explained by to lack of publications supporting their use for the removal of
endometrial polyps. The Duckbill polyp snare has
been investigated in two studies, which showed the snare is a safe and
efficient method and is well tolerated by patients.
In 2005 a new technology has become available called the hysteroscopic
morcellator. Two recently conducted randomized
controlled trials showed an overall efficacy of 92-98%.
The Duckbill polyp snare has two important advantages over the hysteroscopic
morcellator. The snare can be used down the
operating channel of a variety of continuous flow hysteroscopes, which are
already being used in day-to-day use in
gynaecological practice in outpatient settings. In contrast, the hysteroscopic
morcellator system requires acquisition of specific
hysteroscopes. Another advantage are the costs of the device, which are about
six times lower for the Duckbill polyp snare in
comparison with the hysteroscopic morcellation with a purchase price of
respectively 55 euro and 304,32 euro.
Studies in which the hysteroscopic morcellator is compared with the Duckbill
polyp snare are lacking therfore it is uncertain
which method is the first choice method to remove endometrial polyps in an
outpatient setting.

The objective of this monocenter, single-blinded, randomised controlled trial
is to evaluate the effectiveness and cost-effectiveness of the Duckbill polyp
snare in comparison with the hysteroscopic morcellator.

Hypothesis: We hypothesize that snare resection is non-inferior to
hysteroscopic morcellation. Furthermore we expect snare resection is
cost effective in comparison with hysteroscopic morcellation.

Research questions
In undertaking this trial we aim to answer the following research questions:
* Is snare resection non-inferior to hysteroscopic morcellation in the removal
of endometrial polyps in an outpatient setting?
* Is snare resection cost-effective in comparison with hysteroscopic
morcellation in the outpatient setting?

Non-inferiority study: monocenter, randomised controlled trial.

The Duckbill polyp snare (Cook medical)operates by placing the loop to the base
of the polyp after which the loop is closed and
the wire is charged with appropriate current. Then the floating polyp is caught
with the snare, and the polyp tissue is removed.
We will organize a masterclass for all gynecologists of the centers that have
agreed to participate in the study. By organizing
this masterclass we guarantee equality in technique for both procedures among
the participating gynecologists.

There are no extra burdens or risks associated with participation in this
trial. Women with an endometrial polyp and complaints of abnormal bloodloss
will get an hysteroscopic polypresection. This is either with the morcellator
or the Duckbill snare. The accompanying risks are associated with the
hysteroscopy, not with the methode of resection.
Complications that can accur with a hysteroscopy is perforation of the uterine
wall. The uterus consists of musclefibers, so in case of perforation the uterus
will contract and the perforation will heal. In very rare occasions, a
laparoscopy is needed to repair the perforation.

Because of the secondary objective: recurrence of the polyp within a year, we
would like to have a follow up appointment in 1 year after resection.
This appointment would be an extra 'burden' which the patient wouldn't have if
they did not participate in this study.