Clinical trial NCT04702399: Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy
Official title: Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy by the Abdominal Route: Prospective,Randomized, Multicenter and Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With an Indication for Myomectomy or Polymyomectomy
Keywords: Synechia
Myomas
Myomectomy
Polymyomectomy
Gynaecology
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients with endometrial synechiae
timeFrame: 6 weeks after surgery (+/-2weeks)
Secondary outcomes:
measure: Proportion of patients with moderate or severe endometrial synechiae
timeFrame: 6 weeks after surgery (+/-2 weeks)
measure: Proportion of patients with increased of menstrual bleeding or menstrual bleeding time
timeFrame: 6 weeks after surgery (+/- 2 weeks)
measure: The quality of life
timeFrame: 6 weeks after surgery (+/- 2 weeks)
measure: Dysmenorrhea
timeFrame: 6 weeks after surgery (+/- 2 weeks)
measure: Spontaneous pelvic pain
timeFrame: 6 weeks after surgery (+/- 2 weeks)
measure: Metrorragia
timeFrame: 6 weeks after surgery (+/- 2 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Geoffroy Doctor CANLORBE
role: STUDY_DIRECTOR
References: