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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05683041
Other study ID # ONZ-2022-0355
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 22, 2023
Est. completion date December 2024

Study information

Verified date May 2024
Source University Hospital, Ghent
Contact Steffi Van Wessel, Dr.
Phone 093320758
Email studieco.vrouwenkliniek@uzgent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Ghent Nordic Pharma SAS

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adhesion formation postoperatief. The presence of intra-uterine adhesions on a second look hysteroscopy. 3 months post surgery
Secondary Severity of adhesion formation American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity. 3 months post surgery, at the time of the hysteroscopy.
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