Myoma Clinical Trial
Official title:
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
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: - 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 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. ;
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