Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2028-01-31

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.

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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.

Conditions

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Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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intrauterine gel application

Application of Hyalobarrier intrauterine after myomectomy.

Group Type EXPERIMENTAL

Hyalobarrier

Intervention Type DEVICE

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

no intra-uterine gel application

No application of Halobarrier intrauterine after myomectomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyalobarrier

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

Intervention Type DEVICE

Other Intervention Names

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anti-adhesive gel

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes