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PREVENDO is a prospective, multicenter, pilot, and randomized study in 2 parallel arms and single blind, evaluating the proportion of endometrial synechiae 6 weeks after surgery in patients undergoing abdominal myomectomy or polymyomectomy, according to the application or not of an anti-adhesion gel (HYALOBARRIER® GEL ENDO)
Myomas are a common pathology affecting a large population of women of reproductive age. Depending on their location and the patient's symptoms, surgical removal of fibroids may be indicated.
Interstitial or subserous myomas are accessible through the abdominal route (laparotomy or minimally invasive surgery).
The impact of this surgery on the endometrial cavity and the risk of post-surgery synechiae is poorly understood, although it is essential, especially in a population of women wishing to preserve their fertility. In order to reduce and prevent endometrial synechia formation, we suggest PREVENDO study which consist in the systematic intracavitary placement of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) immediately after surgery in patients undergoing abdominal myomectomy or polymyomectomy (laparotomy, laparoscopy, robot-assisted laparoscopy) and the evaluation of the proportion of endometrial synechiae 6 weeks after surgery in patients during diagnostic hysteroscopy performed 6 weeks after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEL GROUP | Experimental | Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO) |
|
| CONTROL GROUP | No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEL GROUP | Device | Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with endometrial synechiae | The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery. | 6 weeks after surgery (+/-2weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with moderate or severe endometrial synechiae | The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery.Severity is assessed using the American Fertility Society score (AFS) | 6 weeks after surgery (+/-2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geoffroy Doctor CANLORBE | Contact | 01 42 17 81 11 | geoffroy.canlorbe@aphp.fr | |
| Henri Doctor AZAIS | Contact | 01 56 09 54 14 | henri.azais@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Geoffroy Doctor CANLORBE | Assistance Publique - Hôpitaux de Paris | Study Director |
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Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D009214 | Myoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Proportion of patients with increased of menstrual bleeding or menstrual bleeding time | Assessed subjectively by patients (Increase vs No increase) | 6 weeks after surgery (+/- 2 weeks) |
| The quality of life | Assessed using EQ-5D-5L questionnary. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none, slight, moderate, severe or unable to perform. Levels are coded 1-5 and a total score is then generated. | 6 weeks after surgery (+/- 2 weeks) |
| Dysmenorrhea | Assessed using the visual analogic scale (VAS) | 6 weeks after surgery (+/- 2 weeks) |
| Spontaneous pelvic pain | Assessed using the visual analogic scale (VAS) | 6 weeks after surgery (+/- 2 weeks) |
| Metrorragia | Assessed subjectively by patients | 6 weeks after surgery (+/- 2 weeks) |