Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Myoma Clinical Trial

— PALLM  

Official title:

Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05683041
• Other study ID #: ONZ-2022-0355
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Myoma
• Tissue Adhesions

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.