Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Conditions
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Myoma

Intervention / Treatment
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* Device: Hyalobarrier


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intrauterine gel application<br>Application of Hyalobarrier intrauterine after myomectomy. | Device: Hyalobarrier<br>* Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.<br>* Other names: anti-adhesive gel;|
| No Intervention: no intra-uterine gel application<br>No application of Halobarrier intrauterine after myomectomy. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative adhesions, Intrauterine adhesions, Myomectomy, Laparoscopic myomectomy, Laparotomic myomectomy, Adhesion prevention, Antiadhesion method