University Hospital Ghent
Ghent, Belgium
Location status: Recruiting
Recruiting
NCT Number: NCT05683041
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hyalobarrier
DeviceHyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.
Other names: anti-adhesive gel
Primary outcomes
-
Adhesion formation postoperatief.
Time frame: 3 months post surgery
The presence of intra-uterine adhesions on a second look hysteroscopy.
Secondary outcomes
-
Severity of adhesion formation
Time frame: 3 months post surgery, at the time of the hysteroscopy.
American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity.
Study contacts
Contact information is provided by the study sponsor or research team.
Steffi Van Wessel, Dr.
CONTACT
Steven Weyers, Prof. dr.
CONTACT
Sponsors and collaborators
Lead sponsor
University Hospital, Ghent
Other
Collaborators
- Nordic Pharma SAS
Registry information
Acronym: PALLM
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jan 12, 2023
- Registry last updated
- Jan 27, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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