Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
ConditionMyoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
Qualifiers
age between 18 and 45 years.
intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy
Disqualifiers
pregnancy.
laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
presence of endometritis.
other antiadhesion methods
Trial design
Treatments tested in this trial
- Hyalobarrier
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Ghent
Lead sponsor
Nordic Pharma SAS
Collaborator
Source ClinicalTrials.gov