Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyalobarrier.
- Who it may be relevant to
- Registry conditions: Myoma. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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.
Interventions
- Device Hyalobarrier
Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.
Primary outcome measures
- Adhesion formation postoperatief. [Time frame: 3 months post surgery]
Secondary outcome measures (1)
- Severity of adhesion formation [Time frame: 3 months post surgery, at the time of the hysteroscopy.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- University Hospital Ghent — Ghent
Identifiers
NCT: NCT05683041 · ONZ-2022-0355