Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy (PALLM)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Myoma

Treatments: Device: Hyalobarrier

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05683041

ONZ-2022-0355

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

intrauterine gel application

Experimental group

Description:

Application of Hyalobarrier intrauterine after myomectomy.

Treatment:

Device: Hyalobarrier

no intra-uterine gel application

No Intervention group

Description:

No application of Halobarrier intrauterine after myomectomy.