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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hyalobarrier
DeviceHyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: intrauterine gel applicationExperimental treatment 1 intervention
Group B: no intra-uterine gel applicationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Adhesion formation postoperatief.
The presence of intra-uterine adhesions on a second look hysteroscopy.
Time frame
3 months post surgerySecondary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
Nordic Pharma SAS
Collaborator
Source ClinicalTrials.gov