Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy (PREVENDO)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Patients With an Indication for Myomectomy or Polymyomectomy

Treatments: Device: GEL GROUP

Study type: Interventional

Funder types: Other

Identifiers

NCT04702399

APHP200247

Details and patient eligibility

About

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)

Full 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.

Enrollment: 76 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

GEL GROUP

Experimental group

Description:

Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO)

Treatment:

Device: GEL GROUP

CONTROL GROUP

No Intervention group

Description:

No Intervention