Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy

Endometrial Polyps Clinical Trial

— RESMO  

Official title:

Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02472197
• Other study ID #: 6043
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: July 2018

Study information

• Verified date: September 2017
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ...)

Related Conditions & MeSH terms

• Endometrial Polyps
• Polyps
• Uterine Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	University Hospital, Strasbourg, france	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The completeness of resection or not,		10 weeks after surgery
Secondary	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
Secondary	The amount of serum used (mL)		At the end of surgery
Secondary	Perioperative complications,		10 weeks after surgery
Secondary	The quality of vision defined by the operator on a scale of 0 to 5,		At the end of surgery
Secondary	Persistence or not of the disease	evaluated by hysteroscopy	10 weeks after surgery
Secondary	The occurrence of secondary adhesions		10 weeks after surgery