Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Not Applicable

Recruiting

• Conditions: Myoma
• Interventions: Device: Hyalobarrier

• Registration Number: NCT05683041
• Lead Sponsor: University Hospital, Ghent

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-12
• Study Start: 2023-02-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrauterine gel application	Hyalobarrier	Application of Hyalobarrier intrauterine after myomectomy.

Primary Outcome Measures

Name	Time	Method
Adhesion formation postoperatief.	3 months post surgery	The presence of intra-uterine adhesions on a second look hysteroscopy.

Secondary Outcome Measures

Name	Time	Method
Severity of adhesion formation	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.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium