Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy by the Abdominal Route: Prospective,Randomized, Multicenter and Pilot Study.

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.

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