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Hyaluronic Acid for the Prevention of Endocavitary Synechiae After Myomectomy

76 participantsStarted 2021-02-01

Plain-language 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)

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The proportion of patients with endometrial synechiae

Timeframe: 6 weeks after surgery (+/-2weeks)

Trial details

NCT IDNCT04702399

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

Contact for this trial

Geoffroy Doctor CANLORBE

01 42 17 81 11 geoffroy.canlorbe@aphp.fr

View on ClinicalTrials.gov More Patients With an Indication for Myomectomy or Polymyomectomy trials