Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

Not Applicable

• Conditions: Patients With an Indication for Myomectomy or Polymyomectomy
• Interventions: Device: GEL GROUP

• Registration Number: NCT04702399
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Study Start: 2021-02-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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)
Dysmenorrhea	6 weeks after surgery (+/- 2 weeks)	Assessed using the visual analogic scale (VAS)