Trial Information

A Randomised Controlled Trial Comparing Morcellation With Electrical Resection for Removal of Uterine Polyps

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 or inpatient hospital admission. The most common
operative hysteroscopic procedure is endometrial polypectomy and the feasibility and
acceptability of such approaches has been demonstrated. The procedure involves removing
polyps from the uterine cavity. Over 90% of UK gynaecologists routinely recommend removal of
endometrial polyps following diagnosis with the aim of treating associated symptoms of
abnormal bleeding and retrieving the specimen to exclude malignant or pre-malignant disease.
The investigators have recently completed recruitment to a large, multicentre, randomised
control trial called the Outpatient Polypectomy Trial ('OPT' http://www.opt.bham.ac.uk,
ISRCTN65868569), which has compared treatment settings for the removal of endometrial
polyps. Over 500 women were randomised between outpatient procedures and day-case procedures
which require a general anaesthetic. The analysis regarding relative treatment effectiveness
will be available in late 2012. Interestingly, this trial also recruited women who expressed
a preference for treatment setting. This resulted in an additional 400 women entering the
study of which over 90% had a preference for an outpatient setting (Personal communication
Clark TJ).

Thus outpatient removal of polyps is, feasible, safe and preferred by women. The majority of
gynaecologists performing outpatient procedures, cut polyps away from their attachment to
the uterine wall using a miniature bipolar electrosurgical instrument; Versapoint®
(Gynecare; Ethicon Inc., New Jersey, USA). This procedure is carried out under direct
hysteroscopic vision, without the need for routine, potentially painful, dilatation of the
cervix. Whilst the technology is feasible and effective it requires skill and experience in
outpatient hysteroscopic surgery, which many UK gynaecologists lack and this is reflected in
the limited adoption of outpatient procedures in spite of evidence supporting their use.
Moreover, even for the experienced operator, retrieving the removed polyp specimen from the
uterine cavity, to send off for histopathological assessment, can be a challenge due to the
small operating field and the need to negotiate the narrower endocervical canal. Various
methods are used to retrieve specimens and include the use of mechanical instruments (e.g.
grasping forceps or snares) which do not require the cervix to be dilated. However, this
approach often fails because of the fragility of these minute hysteroscopic instruments
(diameter 1.2-1.8mm) so recourse to insertion of larger 'polyp' forceps blindly into the
uterine cavity is necessary. The latter approach requires the use of local injection of
anaesthetic into the cervix which is uncomfortable and dilatation of the cervix with the
potential for uterine trauma.

Since, completion of recruitment of OPT trial a new technology has become available called
the TRUCLEAR hysteroscopic morcellator (Smith&Nephew, Andover MASS, USA). This technology
incorporates a 4mm disposable mechanical cutting device which simultaneously cuts and
aspirates polyp tissue. The ability to both cut and retrieve polyps avoids the need for
additional instrumentation of the uterine cavity in order to retrieve the detached polyp
specimen i.e. a single insertion of the hysteroscope is required only. The use of mechanical
morcellation may also improve visualisation during surgery by avoidance of bubble formation
or the production of tissue fragments ('chips') associated with the electrosurgical
approach. Thus, this new technology has potential advantages for the patient (acceptability,
pain, infection, safety), the surgeon (speed, feasibility, completeness of the procedure)
and health service (avoidance of second stage procedures under general anaesthetic).
However, the established single use bipolar electrode is smaller than the disposable
morcellator cutting device (1.6mm vs. 2.9mm). Moreover, the bipolar electrode can be used
down the operating channel of a variety of continuous flow hysteroscopes which are longer
and smaller in diameter and in day-to-day use in gynaecological practice in outpatient
settings (outer diameter 4.1mm (Gynecare; Ethicon Inc., New Jersey, USA), 5mm Storz Bettocci
hysteroscope (Karl Storz Endoscopy-America inc., California, USA) or Olympus 5.5mm (Olympus
Corporation, Shinjuku-ku, Tokyo, Japan). In contrast, the hysteroscopic morcellator system
is larger (5.6mm outer diameter) and requires acquisition of specific hysteroscopes with an
offset proximal eyepiece to allow the rigid mechanical cutting device to be inserted in
direct alignment with the barrel of the hysteroscope. Thus in an outpatient setting, the
bipolar electrode may have advantages over the larger hysteroscopic morcellator in terms of
ease of uterine instrumentation.

In view of the development of hysteroscopic morcellation and potential advantages associated
with this innovation in hysteroscopic instrumentation, the investigators believe that there
is an urgent need to undertake a robust health technology assessment. It is timely to
perform an RCT now before the findings of the OPT trial are available (which will recommend
outpatient as opposed to day-case treatment if increased cost-effectiveness is
demonstrated). If the morcellator is considered an easier technology to use by
gynaecologists (i.e. less operator skill required), then there is a danger that it will
become widely adopted for outpatient use without supporting evidence of benefit.