The Hysteroscopic Morcellator (HM).

NCT01537822 | Completed

• 1 other identifier: 2011/679
• Study Type: interventional
• Target: 253
• Locations: 2 countries
• Sites: 2

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.

Conditions

Large Intrauterine Polyps; Smaller Type 0 and 1 Myomas; Residual Placental Tissue

Keywords

intrauterine polyps; myomas; residual placental tissue

Outcome Measures

Primary Outcomes (2)

• Installation time and operating time.

  Installation time is defined as the time to set up the hysteroscopic instrumentation ready for use (time from start of setting up the instrumentation to start resection / morcellation). Operating time is defined as the time starting visual introduction of the hysteroscope until the time at which the procedure is completed and the hysteroscope is removed definitely. Times will be measured with a stop watch by a trained nurse.

  the length of the operation

• Check for adhesions during follow-up.

  Ambulant diagnostic hysteroscopy is performed at 6 weeks postoperative follow-up.

  After 6 weeks, during follow-up visit

Secondary Outcomes (2)

• Fluid deficit

  during the length of the operation

• complications and complaints

  between operation until 6 weeks follow-up

Other Outcomes (3)

• Pregnancy rate

  between the hysteroscopic removal of residual placental tissue and the first clinical pregnancy up to 7 years of follow-up

• Pregnancy outcome

  the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up

• Pregnancy complication

  the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up

Study Arms (2)

hysteroscopic morcellator

EXPERIMENTAL

Women, randomized into getting a treatment with the hysteroscopic morcellator.

Procedure: Hysteroscopic morcellator

Resectoscope

ACTIVE COMPARATOR

Women, randomized into getting a treatment with the resectoscope.

Procedure: Resectoscope

Interventions

Hysteroscopic morcellator PROCEDURE

Morcellation will be performed with the HM (TRUCLEAR, Smith \& Nephew, Andover, USA). The rotary blade is used for polypectomy and removal of residual placental tissue; the reciprocating blade is used for myomectomy. The blade has a window-opening at the end with cutting edges through which tissue is aspirated by means of a vacuum source. The removed tissue is discharged through the device, collected in a pouch and made available for pathology analysis.

hysteroscopic morcellator

Resectoscope PROCEDURE

Resectoscopy will be performed with a rigid 8.5 mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany), equipped with a 0 or 30 degree optic. Normal saline is used for distension and irrigation of the uterine cavity. Fluid balance is closely monitored using a Hystero pump (Richard Wolf GmbH, Knittlingen, Germany) or Hysteromat pump (Karl Storz GmbH, Tuttlingen, Germany).

Resectoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Catharina Hospital Eindhoven

Eindhoven, 5602 ZA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 26192235 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Steven Weyers, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 23, 2012
• Study Start: May 1, 2011
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 4, 2021

Record last verified: 2019-10

Locations

NL (1); BE (1)