NCT05683041

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Feb 2023Jan 2028

First Submitted

Initial submission to the registry

December 20, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 22, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

December 20, 2022

Last Update Submit

January 22, 2025

Conditions

Myoma

Keywords

Postoperative adhesionsIntrauterine adhesionsMyomectomyLaparoscopic myomectomyLaparotomic myomectomyAdhesion preventionAntiadhesion method

Outcome Measures

Primary Outcomes (1)

  • Adhesion formation postoperatief.

    The presence of intra-uterine adhesions on a second look hysteroscopy.

    3 months post surgery

Secondary Outcomes (1)

  • Severity of adhesion formation

    3 months post surgery, at the time of the hysteroscopy.

Study Arms (2)

intrauterine gel application

EXPERIMENTAL

Application of Hyalobarrier intrauterine after myomectomy.

Device: Hyalobarrier

no intra-uterine gel application

NO INTERVENTION

No application of Halobarrier intrauterine after myomectomy.

Interventions

HyalobarrierDEVICE

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

Also known as: anti-adhesive gel
intrauterine gel application

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly woman included with uterus.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy.
  • laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
  • presence of endometritis.
  • other antiadhesion methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

MyomaGynatresia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Steffi Van Wessel, Dr.

CONTACT

093320758studieco.vrouwenkliniek@uzgent.be

Steven Weyers, Prof. dr.

CONTACT

093320758studieco.vrouwenkliniek@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 12, 2023

Study Start

February 22, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)