Prevention of Intra-uterine Adhesions Following Laparosco... | NCT05683041

Studies
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

NCT05683041

Sponsor

University Hospital, Ghent

Status

Recruiting

Last Update Posted

Jan 27, 2025Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Myoma

Interventions

Hyalobarrier

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2023Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Dec 20, 2022

First Submission Date that Met QC Criteria

Jan 5, 2023

First Posted Date

Jan 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2025

Last Update Posted Date

Jan 27, 2025Actual

Name	Class
Nordic Pharma SAS	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hyalobarrier	Device	Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.	intrauterine gel application

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

only woman included with uterus.

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Steffi Van Wessel, Dr.	Contact	093320758		studieco.vrouwenkliniek@uzgent.be
Steven Weyers, Prof. dr.	Contact	093320758		studieco.vrouwenkliniek@uzgent.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent	Recruiting	Ghent			Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009214	Myoma
D006175	Gynatresia

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

Masking

Triple

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.

Who Masked

ParticipantCare ProviderInvestigator