To compare the HM to bipolar resectoscopy for removal of residual placental tissue in terms of efficiency and complications.
ID
Source
Brief title
Condition
- Placental, amniotic and cavity disorders (excl haemorrhages)
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Installation and operating time.
Performing a second look hysteroscopy after 6 weeks checking for intrauterine
adhesions, comparing the 2 techniques.
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 lesions such as myomas, polyps and residual placental tissue. It
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. Data on removal of residual placental tissue by repetition
of curettage show a high risk of adhesion formation.
Study objective
To compare the HM to bipolar resectoscopy for removal of residual placental
tissue 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
residual placental tissue is suspected. To confirm the diagnosis an 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 postoperative visit with second look hysteroscopy, checking for
intrauterine adhesions, 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 operating 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. Moreover we will
check whether the HM has a lower risk of intrauterine adhesion formation, as
this might influence patient*s fertility.
Postbus 1350
5602 ZA Eindhoven
NL
Postbus 1350
5602 ZA Eindhoven
NL
Listed location countries
Age
Inclusion criteria
Patients with residual placental tissue as seen by ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
Exclusion criteria
Patients with:
• 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 | NL34646.060.10 |