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

University Hospital, Strasbourg, France

Status

Completed

Conditions

Endometrial Polyps

Treatments

Procedure: Standard hysteroscopic resection

Procedure: Hysteroscopic morcellation

Study type

Interventional

Funder types

Other

Identifiers

NCT02472197

6043

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 ...)