Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy (RESMO)

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Polyps
• Intervention / Treatment: Procedure: Hysteroscopic morcellation; Procedure: Standard hysteroscopic resection

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • University Hospital, Strasbourg, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 ...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: morcellation	Procedure: 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.
Active Comparator: standard resection	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morcellation or resection time (minutes)	From the cervical dilatation just before introducing the operative device until removal of the operative device assessed up to 25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completeness of resection or not,		10 weeks after surgery
The total operating time (in minutes):		from the beginning of diagnostic hysteroscopy to the end of operative hysteroscopy resection and removal of the operative device, assessed up to 25 minutes
The amount of serum used (mL)		At the end of surgery
Perioperative complications,		10 weeks after surgery
The quality of vision defined by the operator on a scale of 0 to 5,		At the end of surgery
Persistence or not of the disease	evaluated by hysteroscopy	10 weeks after surgery
The occurrence of secondary adhesions		10 weeks after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Olivier GARBIN, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Endometrial polyp; Hysteroscopic resection; Morcellation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: 6043