RecruitingNot ApplicableNCT05683041

Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Sponsor

University Hospital, Ghent

Enrollment

30 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Myoma

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

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 Criteria4

pregnancy.
laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
presence of endometritis.
other antiadhesion methods

Interventions

DEVICEHyalobarrier

Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.

Locations(1)

University Hospital Ghent

Ghent, Belgium

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NCT05683041