Preventing adhesions after myomectomy surgery
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
NA · University Hospital, Ghent · NCT05683041
This study is testing whether a special gel used during myomectomy surgery can help prevent scar tissue from forming in women aged 18 to 45, which could improve their chances of getting pregnant later.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT05683041 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of an intrauterine gel in preventing intrauterine adhesions following laparoscopic or laparotomic myomectomy in women aged 18 to 45 with specific types of myomas. It is a double-blind, randomized controlled pilot trial where participants will either receive the gel or a control treatment during their surgery. A follow-up hysteroscopy will be conducted three months post-surgery to assess adhesion formation. The study aims to improve fertility outcomes by reducing postoperative complications associated with myomectomy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 with specific types of myomas scheduled for myomectomy and without pre-existing intrauterine adhesions.
Not a fit: Patients who are pregnant, have endometritis, or are undergoing combined operative hysteroscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance fertility prospects for women undergoing myomectomy by reducing the risk of intrauterine adhesions.
How similar studies have performed: Other studies have shown promise in using similar antiadhesion methods, but this specific approach with Hyalobarrier® gel is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent
- University Hospital Ghent — Ghent, Belgium (RECRUITING)
Study contacts
- Study coordinator: Steffi Van Wessel, Dr.
- Email: studieco.vrouwenkliniek@uzgent.be
- Phone: 093320758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myoma, Postoperative adhesions, Intrauterine adhesions, Myomectomy, Laparoscopic myomectomy, Laparotomic myomectomy, Adhesion prevention, Antiadhesion method