Patients With an Indication for Myomectomy or Polymyomectomy
Conditions
Keywords
Synechia, Myomas, Myomectomy, Polymyomectomy, Gynaecology
Brief summary
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)
Detailed description
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.
Interventions
DEVICEGEL GROUP
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Of childbearing age 3. Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy 4. FIGO 2 to 6 classification myomas
Exclusion criteria
1. History of intra uterine synechia treatment 2. Uterine malformation 3. Patients under legal protection measure (guardianship or curatorship) or under security measure 4. Pregnant or breastfeeding women 5. Absence of health insurance; or patient with AME 6. Absence of free, informed and written consent 7. Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy) 8. Patient with upper genital infection 9. Hypersensibility to hyaluronic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with endometrial synechiae | 6 weeks after surgery (+/-2weeks) | The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with increased of menstrual bleeding or menstrual bleeding time | 6 weeks after surgery (+/- 2 weeks) | Assessed subjectively by patients (Increase vs No increase) |
| The quality of life | 6 weeks after surgery (+/- 2 weeks) | 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. |
| Proportion of patients with moderate or severe endometrial synechiae | 6 weeks after surgery (+/-2 weeks) | 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) |
| Spontaneous pelvic pain | 6 weeks after surgery (+/- 2 weeks) | Assessed using the visual analogic scale (VAS) |
| Metrorragia | 6 weeks after surgery (+/- 2 weeks) | Assessed subjectively by patients |
| Dysmenorrhea | 6 weeks after surgery (+/- 2 weeks) | Assessed using the visual analogic scale (VAS) |
Contacts
Primary ContactGeoffroy Doctor CANLORBE
Backup ContactHenri Doctor AZAIS
Outcome results
None listed