Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy (PREVENDO)

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

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)

Study Overview

• Status: Unknown
• Conditions: Patients With an Indication for Myomectomy or Polymyomectomy
• Intervention / Treatment: Device: GEL GROUP

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GEL GROUP; Intracavitary application of an anti-adhesion hyaluronic acid gel (HYALOBARRIER® GEL ENDO)	Device: GEL GROUP; Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
NO_INTERVENTION: CONTROL GROUP; No Intervention

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Geoffroy Doctor CANLORBE, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (ACTUAL): January 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Myomectomy; Myomas; Gynaecology; Synechia; Polymyomectomy
• Other Study ID Numbers: APHP200247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No