An interventional study of Hysteroscopic morcellator and Resectoscope in Large Intrauterine Polyps, Smaller Type 0 and 1 Myomas and Residual Placental Tissue, sponsored by University Hospital, Ghent. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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:
Study design: Single blind, randomized controlled multicenter trial.
Study population: Women aged over 18 years old with:
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.
61 studies on the registry are indexed under Myoma; 10 are open to participants now.
This study's enrollment of 253 is above the median of 80 across 45 interventional studies indexed under Myoma.
Browse Myoma studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women, randomized into getting a treatment with the hysteroscopic morcellator.
Procedure: Hysteroscopic morcellator
Women, randomized into getting a treatment with the resectoscope.
Procedure: Resectoscope
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.
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).
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.
Time frame: the length of the operation
Check for adhesions during follow-up.
Ambulant diagnostic hysteroscopy is performed at 6 weeks postoperative follow-up.
Time frame: After 6 weeks, during follow-up visit
Fluid deficit
Fluid deficit in both procedures is the result of subtracting the outflow volumes from the inflow volumes as measured by the pump.
Time frame: 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.
Time frame: between operation until 6 weeks follow-up
Pregnancy rate
number of pregnancies / number of women wishing to conceive
Time frame: between the hysteroscopic removal of residual placental tissue and the first clinical pregnancy up to 7 years of follow-up
Pregnancy outcome
Pregnancy outcome (biochemical / EUG / miscarriage / fetal demise / live birth)
Time frame: the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up
Pregnancy complication
Pregnancy complication (vaginal blood loss / preterm contractions / PPROM / pregnancy induced hypertension / preeclampsia / eclampsia / uterine rupture)
Time frame: the first pregnancy subsequent to the hysteroscopic removal of residual placental tissue up to 7 years of follow-up
The record gives a start of May 2011, a primary completion of Jul 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.