Overview
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.
Description
- 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.
Eligibility
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