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NCT04702399 Clinical Trial

Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

Patients With an Indication for Myomectomy or Polymyomectomy Clinical Trial

— PREVENDO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04702399
Other study ID # APHP200247
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date May 1, 2022

Study information
Verified date November 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Geoffroy Doctor CANLORBE
Phone 01 42 17 81 11
Email geoffroy.canlorbe@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 76
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • Patients With an Indication for Myomectomy or Polymyomectomy

Intervention

Device:
• GEL GROUP
Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary Dysmenorrhea Assessed using the visual analogic scale (VAS) 6 weeks after surgery (+/- 2 weeks)
Secondary Spontaneous pelvic pain Assessed using the visual analogic scale (VAS) 6 weeks after surgery (+/- 2 weeks)
Secondary Metrorragia Assessed subjectively by patients 6 weeks after surgery (+/- 2 weeks)