Clinical trial NCT01537822: The Hysteroscopic Morcellator (HM).
Official title: The Hysteroscopic Morcellator Versus the Bipolar Resectoscope for Removal of Lager Intrauterine Polyps, Removal of Submucous Myomas and Removal of Residual Placental Tissue: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Large Intrauterine Polyps
Smaller Type 0 and 1 Myomas
Residual Placental Tissue
Keywords: intrauterine polyps
myomas
residual placental tissue
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 253
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale:

The hysteroscopic morcellator (HM) is a novel technique for removal of intrauterine polyps, myomas and 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.

Objective:

To compare the HM to bipolar resectoscopy for removal of:

1) large intrauterine polyps, 2) smaller type 0 and 1 myomas, 3) residual placental tissue, in terms of efficiency and complications.

Study design: Single blind, randomized controlled multicenter trial.

Study population: Women aged over 18 years old with:

1) large (≥ 1 cm) intrauterine polyps, 2) smaller (≤ 3 cm) type 0 or 1 myomas, 3) residual placental tissue, who are planned for hysteroscopic removal.

Intervention:

Patients are randomized between removal with the HM or the bipolar resectoscope.

Main study parameters/endpoints:

Installation and operating time.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

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 intrauterine pathology 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 hospitals and the choice of treatment depends on the preference of the gynaecologist. 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 and/or ambulant diagnostic hysteroscopy 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.

After completion of the RCT, an observational study is planned considering pregnancies subsequent to the hysteroscopic procedure.


Eligibility criteria: Inclusion Criteria:

* Patients with one or more intrauterine polyp(s) with a diameter ≥ 1 cm as seen on ultrasound, confirmed by saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.
* 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.
* Patients with residual placental tissue as seen by ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery.

Exclusion Criteria:

* Only polyps \< 1cm (Note: intrauterine polyps \< 1 cm are treated in an ambulatory setting).
* 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.
* With a contra-indication for operative hysteroscopy.

Primary outcomes:
measure: Installation time and operating time.
timeFrame: the length of the operation
measure: Check for adhesions during follow-up.
timeFrame: After 6 weeks, during follow-up visit
Secondary outcomes:
measure: Fluid deficit
timeFrame: during the length of the operation
measure: complications and complaints
timeFrame: between operation until 6 weeks follow-up
Other outcomes:
measure: Pregnancy rate
timeFrame: between the hysteroscopic removal of residual placental tissue and the first clinical pregnancy up to 7 years of follow-up
measure: Pregnancy outcome
timeFrame: the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up
measure: Pregnancy complication
timeFrame: the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
Study officials:
affiliation: University Hospital, Ghent
name: Steven Weyers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamerlynck TW, Schoot BC, van Vliet HA, Weyers S. Removal of Endometrial Polyps: Hysteroscopic Morcellation versus Bipolar Resectoscopy, A Randomized Trial. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1237-43. doi: 10.1016/j.jmig.2015.07.006. Epub 2015 Jul 17.