An interventional study of Hyalobarrier in Myoma, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Prevention
Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.
Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.
Design:
Double-blind, randomized controlled pilot trial.
Participant:
Treatment:
Application of intrauterine Hyalobarrier® gel endo at time of surgery
Control:
No application of Hyalobarrier® gel endo
Follow up:
Second-look hysteroscopy after 3months
To blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.
Exclusion Criteria:
Application of Hyalobarrier intrauterine after myomectomy.
Device: Hyalobarrier
No application of Halobarrier intrauterine after myomectomy.
Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.
Also known as: anti-adhesive gel
Adhesion formation postoperatief.
The presence of intra-uterine adhesions on a second look hysteroscopy.
Time frame: 3 months post surgery
Severity of adhesion formation
American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity.
Time frame: 3 months post surgery, at the time of the hysteroscopy.
Plan to share: No
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University Hospital, Ghent