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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
76
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
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.
Time frame: 6 weeks after surgery (+/-2weeks)
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)
Time frame: 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)
Time frame: 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.
Time frame: 6 weeks after surgery (+/- 2 weeks)
Dysmenorrhea
Assessed using the visual analogic scale (VAS)
Time frame: 6 weeks after surgery (+/- 2 weeks)
Spontaneous pelvic pain
Assessed using the visual analogic scale (VAS)
Time frame: 6 weeks after surgery (+/- 2 weeks)
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Metrorragia
Assessed subjectively by patients
Time frame: 6 weeks after surgery (+/- 2 weeks)