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Completed

NCT Number: NCT02472197

Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy

Intrauterine pathologies are currently treated by hysteroscopic resection. In this surgical procedure, the intrauterine pathology is resected by a transcervical approach in several fragments using a mono or bipolar cove after distension of the uterine cavity and by endoscopic control. The main risks of this surgery are: uterine perforation and OHIA (operative hysteroscopy intravascular absorption) syndrome. Hysteroscopic morcellators are new intrauterine devices, recently appeared on the French market.

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All major patients with single endometrial polyp,
  • 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

  • Ongoing pregnancy or breastfeeding
  • 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 ...)

Treatment and study plan

Hysteroscopic morcellation

Procedure

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

Procedure

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.

Primary outcomes

  1. Morcellation or resection time (minutes)

    Time frame: From the cervical dilatation just before introducing the operative device until removal of the operative device assessed up to 25 minutes

Secondary outcomes

  1. The completeness of resection or not,

    Time frame: 10 weeks after surgery

  2. The total operating time (in minutes):

    Time frame: from the beginning of diagnostic hysteroscopy to the end of operative hysteroscopy resection and removal of the operative device, assessed up to 25 minutes

  3. The amount of serum used (mL)

    Time frame: At the end of surgery

  4. Perioperative complications,

    Time frame: 10 weeks after surgery

  5. The quality of vision defined by the operator on a scale of 0 to 5,

    Time frame: At the end of surgery

  6. Persistence or not of the disease

    Time frame: 10 weeks after surgery

    evaluated by hysteroscopy

  7. The occurrence of secondary adhesions

    Time frame: 10 weeks after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: RESMO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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