Large Intrauterine PolypsHMNCT01537822
The Hysteroscopic Morcellator (HM).
A study testing Hysteroscopic morcellator and Resectoscope in people with Large Intrauterine Polyps and Smaller Type 0 and 1 Myomas, run by University Hospital, Ghent at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Large Intrauterine Polyps, Smaller Type 0 and 1 Myomas, Residual Placental Tissue
- What is being tested?
- Hysteroscopic morcellator and Resectoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2011to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
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.
Read more
Objective:
To compare the HM to bipolar resectoscopy for removal of:
- 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:
- 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.
- Being tested
- Hysteroscopic morcellator, Resectoscope
- Keywords
- intrauterine polyps, myomas, residual placental tissue
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic morcellatorProcedure or surgery
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.
ResectoscopeProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| hysteroscopic morcellator | Experimental | Women, randomized into getting a treatment with the hysteroscopic morcellator. Receives: Procedure: Hysteroscopic morcellator |
| Resectoscope | Active comparator | Women, randomized into getting a treatment with the resectoscope. Receives: Procedure: Resectoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the length of the operation
Check for adhesions during follow-up.
Ambulant diagnostic hysteroscopy is performed at 6 weeks postoperative follow-up.
Measured: After 6 weeks, during follow-up visit
Secondary outcomes (2)
Fluid deficit
Fluid deficit in both procedures is the result of subtracting the outflow volumes from the inflow volumes as measured by the pump.
Measured: during the length of the operation
complications and complaints
During the postoperative hospital stay blood samples looking for electrolyte imbalances will only be taken when excessive fluid absorption is suspected based on fluid deficit (> 2500 mL for normal saline) and/or clinical symptoms.
At 6 weeks postoperatively a standard visit is scheduled. Complications and complaints are recorded, and ultrasound is performed.
Measured: between operation until 6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMay 2011
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Large Intrauterine PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Weyers, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537822
- Sponsor's protocol ID
- 2011/679
- Acronym
- HM
- Status last verified
- Oct 2019
- First submitted
- 15 Feb 2012
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26192235
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01537822
- Acronym / sponsor ID
- HM / 2011/679
- Keywords
- intrauterine polyps, myomas, residual placental tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hysteroscopic morcellator | Experimental | Procedure: Hysteroscopic morcellatorWomen, randomized into getting a treatment with the hysteroscopic morcellator. |
| Resectoscope | Active comparator | Procedure: ResectoscopeWomen, randomized into getting a treatment with the resectoscope. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic morcellatorMorcellation 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. | Procedure or surgery | hysteroscopic morcellator |
| ResectoscopeResectoscopy 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). | Procedure or surgery | Resectoscope |
Primary outcome
Installation time and operating time.
Time frame: the length of the operation
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.
Check for adhesions during follow-up.
Time frame: After 6 weeks, during follow-up visit
Ambulant diagnostic hysteroscopy is performed at 6 weeks postoperative follow-up.
2 secondary outcomes
Fluid deficit
Time frame: during the length of the operation
complications and complaints
Time frame: between operation until 6 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 26192235Hamerlynck 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Weyers, MD, PhD principal investigator
University Hospital, Ghent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic morcellator and Resectoscope in people with Large Intrauterine Polyps and Smaller Type 0 and 1 Myomas, run by University Hospital, Ghent at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Installation time and operating time. (time frame: the length of the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.