Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy
NCT ID: NCT02472197
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2015-09-30
2018-07-31
Brief Summary
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In comparison to classical resectors, morcellators have several theoretical advantages:
* A smaller instrument diameter with potentially a lower risk of uterine perforation and cervical laceration during the dilatation procedure,
* The use of physiological serum, eliminating the risk of neurological toxicity of glycine,
* The risk of electrical accident is canceled (internal or external burns due to leakage current),
* A decreased risk of air embolism, due to the absence of bubbles' production,
* The instrument is always under visual control, the perforation risk by the active instrument is therefore very limited,
* The vision is not obscured by the fragments or by the bubbles,
* The treatment of pre-ostial pathologies, not always easy in classical resections, could be facilitated,
* the absence of thermal effect, and therefore a potentially lower endometrial aggression, is interesting in women with reproductive desire,
* Absence of chips management, limiting the entry and exit movements in the uterine cavity, improving the vision, reducing the infectious and traumatic risks, specially uterine perforation and air embolism,
* Morcellation could preserve tissues for histological analysis of possible malignancy (compared to techniques using heat, coagulation, vaporization),
* Easy learning in comparison to the time-consuming learning of classical hysteroscopic resection,
* Generated additional cost could be partly amortized by reducing operating time and complications.
It seemed useful to study this new technology.
The primary purpose was to compare the time of hysteroscopic treatment of uterine polyps between a hysteroscopic morcellator the UNIDRIVE S III / DrillCut-X II-GYN-Shaver (Integrated Bigatti Shaver IBS), Storz®, and a conventional resectoscope.
The secondary purposes were to compare the efficiency, complications and comfort of these techniques.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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morcellation
Hysteroscopic morcellation
The endometrial polyp is resected by a transcervical approach. During the procedure, the polyp is placed by suction against the window of the device, then cut by mechanical energy, in chips which are directly aspirated by the device.
standard resection
Standard hysteroscopic resection
The endometrial polyp is resected by a transcervical approach in several chips using a mono or bipolar cove after distension of the uterine cavity under endoscopic control.
Interventions
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Hysteroscopic morcellation
The endometrial polyp is resected by a transcervical approach. During the procedure, the polyp is placed by suction against the window of the device, then cut by mechanical energy, in chips which are directly aspirated by the device.
Standard hysteroscopic resection
The endometrial polyp is resected by a transcervical approach in several chips using a mono or bipolar cove after distension of the uterine cavity under endoscopic control.
Eligibility Criteria
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Inclusion Criteria
* Confirmed by a diagnostic hysteroscopy
* Greater than or equal to one centimeter in size with no upper size limit
* Patient giving informed consent
* Subject belonging to a social security organisme
Exclusion Criteria
* Progressive malignant gynecological pathology
* Evolutionary Genital infection
* Suspected malignancy before surgery
* Multiple Polyps
* Polypoid hyperplasia
* Associated submucosal myoma
* Person under guardianship
* Patient with contraindication to general anesthesia or spinal anesthesia
* Person in an exclusion period (determined by a previous or ongoing study)
* Inability to give the eprosn informed information (comprehension difficulties ...)
18 Years
FEMALE
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Olivier GARBIN, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Strasbourg, France
Locations
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University Hospital, Strasbourg, france
Strasbourg, , France
Countries
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References
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Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16.
Other Identifiers
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6043
Identifier Type: -
Identifier Source: org_study_id