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NCT05683041
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Conditions: Myoma
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: University Hospital, Ghent
Location: University Hospital Ghent Ghent
Summary
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
Inclusion Criteria:
* 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
Exclusion Criteria:
* pregnancy.
* laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
* presence of endometritis.
* other antiadhesion methods
Source: ClinicalTrials.gov (NCT05683041). StuddyBuddy aggregates publicly available trial information.