Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy (PALLM)

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.

Postoperative adhesions, Intrauterine adhesions, Myomectomy, Laparoscopic myomectomy, Laparotomic myomectomy, Adhesion prevention, Antiadhesion method

This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions. The application of antiadhesion gel is compared to no gel.

None of the participants will be informed of the allocated treatment by the surgeon or the personnel present in the OR. The medical record will not reveal any information whether antiadhesion gel was applied at the end of the procedure. In the case that the surgeon is the same person as the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.

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

American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity.

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