Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Patients With an Indication for Myomectomy or Polymyomectomy

Intervention / Treatment
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* Device: GEL GROUP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Of childbearing age Indication of myomectomy / polymyomectomy by laparotomy / laparoscopy / robot-assisted laparoscopy FIGO 2 to 6 classification myomas Exclusion Criteria: History of intra uterine synechia treatment Uterine malformation Patients under legal protection measure (guardianship or curatorship) or under security measure Pregnant or breastfeeding women Absence of health insurance; or patient with AME Absence of free, informed and written consent Endometrial synechia before operation (grade 1-3) (assessed by systematic diagnostic hysteroscopy) Patient with upper genital infection Hypersensibility to hyaluronic acid

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEL GROUP<br>Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO) | Device: GEL GROUP<br>* Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity<br>|
| No Intervention: CONTROL GROUP<br>No Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with endometrial synechiae | The evaluation of the proportion of endometrial synechiae in patients udergoing abdominal myomectomy or polymyoomectomy, during diagnostic hysteroscopy performed 6 weeks after surgery. | 6 weeks after surgery (+/-2weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with moderate or severe endometrial synechiae | 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) | 6 weeks after surgery (+/-2 weeks) | 
| Proportion of patients with increased of menstrual bleeding or menstrual bleeding time | Assessed subjectively by patients (Increase vs No increase) | 6 weeks after surgery (+/- 2 weeks) | 
| The quality of life | 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. | 6 weeks after surgery (+/- 2 weeks) | 
| Dysmenorrhea | Assessed using the visual analogic scale (VAS) | 6 weeks after surgery (+/- 2 weeks) | 
| Spontaneous pelvic pain | Assessed using the visual analogic scale (VAS) | 6 weeks after surgery (+/- 2 weeks) | 
| Metrorragia | Assessed subjectively by patients | 6 weeks after surgery (+/- 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myomectomy, Synechia, Myomas, Polymyomectomy, Gynaecology