Morcellator Versus Resectoscope in the Treatment of Uterine Polyps by Hysteroscopy

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.

Conditions

• Endometrial Polyps

Interventions

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.

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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France

  lead OTHER

Principal Investigators

• Olivier GARBIN, MD · University Hospital, Strasbourg, France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2018-07-31

Completion

2018-07-31

Countries

• France

Study Locations