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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
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.
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.
University Hospital, Strasbourg, france
Strasbourg, France
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
The completeness of resection or not,
Time frame: 10 weeks after surgery
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
The amount of serum used (mL)
Time frame: At the end of surgery
Perioperative complications,
Time frame: 10 weeks after surgery
The quality of vision defined by the operator on a scale of 0 to 5,
Time frame: At the end of surgery
Persistence or not of the disease
evaluated by hysteroscopy
Time frame: 10 weeks after surgery
The occurrence of secondary adhesions
Time frame: 10 weeks after surgery
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