Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05683041

Acronym

PALLM

Enrollment

Registered

2023-01-12

Start date

2023-02-22

Completion date

2030-01-01

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myoma

Keywords

Postoperative adhesions, Intrauterine adhesions, Myomectomy, Laparoscopic myomectomy, Laparotomic myomectomy, Adhesion prevention, Antiadhesion method

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.

Interventions

DEVICEHyalobarrier

Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

None of the participants will be informed of the allocated treatment by the surgeon or the personnel present in the OR. The medical record will not reveal any information whether antiadhesion gel was applied at the end of the procedure. In the case that the surgeon is the same person as the gynaecologist doing the second-look hysteroscopy, blinding is assured by notification of treatment allocation if the surgeon has left the operating room.

Intervention model description

This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions. The application of antiadhesion gel is compared to no gel.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Belgium

Contacts

CONTACTSteffi Van Wessel, Dr.

studieco.vrouwenkliniek@uzgent.be093320758

CONTACTSteven Weyers, Prof. dr.