Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2021-A01040-41 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique.
This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months.
The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OHR System | Active Comparator | Use of the OHR system to perform an operative hysteroscopy by resection of the fibroid. |
|
| OHV System | Experimental | Use of the OHV system to perform an operative hysteroscopy by vaporization of the fibroid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OHR VS OHV | Procedure | Control group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid. Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time expressed in minutes | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of distention fluid used during operative hysteroscopy | Measured by collection of the distention fluid pockets at the end of the procedure | Baseline |
| Resection time | Time estimated in cm3/min based on ultrasound measurement of the volume of the myoma involved in the resection preoperatively and postoperatively, related to the operative time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aubert Agostini, MD/PhD | Contact | 04 91 38 37 87 | +33 | aubert.agostini@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX, Director | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux Marseille | Recruiting | Marseille | Bouches-du-Rhone | 13354 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline |
| Complication rate during operative hysteroscopy | Cervical tear rate and Rate of uterine perforations | Baseline |
| The rate of discontinuation of the operative hysteroscopy before complete resection | Rate of discontinuation because of uterine perforations, operative time greater than 60 minutes, quantity of distension fluid greater than 9 liters, deficit of distension fluid greater than 1 liter, per operative haemorrhage | Baseline |
| The rate of postoperative synechiae in patients of childbearing age. | Rate of postoperative synechiae diagnosed at follow-up hysteroscopy in patients of childbearing age. | between 6 and 8 weeks after the operation |
| Operative pain | Operative pain evaluated by a visual analog scale (0-100mm). If the patient has a score of 0, it means that he/she has no pain. The higher the value, the more intense the pain. | Baseline |