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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morcellation | Experimental |
| |
| standard resection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopic morcellation | Procedure | 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. |
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier GARBIN, MD | University Hospital, Strasbourg, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Strasbourg, france | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32681995 | Result | Stoll F, Lecointre L, Meyer N, Faller E, Host A, Hummel M, Boisrame T, Akladios C, Garbin O. Randomized Study Comparing a Reusable Morcellator with a Resectoscope in the Hysteroscopic Treatment of Uterine Polyps: The RESMO Study. J Minim Invasive Gynecol. 2021 Apr;28(4):801-810. doi: 10.1016/j.jmig.2020.07.007. Epub 2020 Jul 16. |
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| Standard hysteroscopic resection | Procedure | 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. |
|
| 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 |