To compare the HM to bipolar resectoscopy for removal of smaller type 0 and 1 myomas in terms of efficiency and complications.
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Installation and operation time.
Secondary outcome
Comparing data on peri- and post operative complications (e.g. fluid deficit,
conversion rates, perforation, burns, postoperative infection), availability of
tissue for pathology analysis and pathology results, and efficiency at 6 weeks
follow-up.
Background summary
The hysteroscopic morcellator (HM) is a novel technique for removal of
intrauterine myomas, that withholds some technical advantages over resectoscopy.
Previous data suggest that it*s a faster technique than the latter, and shows
that it has a low complication rate.
Study objective
To compare the HM to bipolar resectoscopy for removal of smaller type 0 and 1
myomas in terms of efficiency and complications.
Study design
Single blind, randomized controlled trial.
Intervention
Patients are randomized between removal with the HM or the bipolar
resectoscope.
Study burden and risks
Women who are referred to our polyclinic will be seen on a first visit, and,
according to the standard work-up, an ultrasound will be performed when an
intrauterine myoma is suspected. To confirm the diagnosis a saline infusion
sonography (SIS) and/or ambulant diagnostic hysteroscopy will be performed
consequently. Once the diagnosis is confirmed and surgery is planned, women
will be asked whether they want to take part in this study. At this moment,
both techniques are used in our hospital and the choice of treatment depends on
the preference of the gynecologist. All women will be treated with operative
hysteroscopy in a daycare setting according to the standard of care, only now
randomized between the two techniques. A standard postoperative visit with
ultrasound examination is scheduled 6 weeks later. Late postoperative
complications and complaints are recorded.
It is expected that the HM beholds some advantages over the bipolar
resectoscope such as shorter operation time and less complications (e.g. risk
of perforation, current and fluid related complications). Previous data do not
demonstrate any additional risks related to the use of the HM.
Postbus 1350
5602 ZA Eindhoven
NL
Postbus 1350
5602 ZA Eindhoven
NL
Listed location countries
Age
Inclusion criteria
Patients with one or more intrauterine myoma(s) with a diameter <= 3 cm as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
Exclusion criteria
Patients with:
• Myomas with a diameter > 3 cm (Note: Myomas > 3 cm are treated with
resectoscopy)
• Type 2 myomas
• Visual or pathological (e.g. on biopsy) evidence of malignancy
preoperatively or at the time of operation.
• Untreated cervical stenosis making safe access for operative hysteroscopy
impossible as diagnosed preoperatively or at the time of operation.
• A contra-indication for operative hysteroscopy.
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 | NL34639.060.10 |