Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids

NCT ID: NCT05078307

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-25
• Study Completion Date: 2024-05-17

Brief Summary

Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique.

This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months.

The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.

Conditions

Uterine Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OHR System

Use of the OHR system to perform an operative hysteroscopy by resection of the fibroid.

Group Type: ACTIVE_COMPARATOR

OHR VS OHV

Intervention Type: PROCEDURE

Control group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid.

Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid.

OHV System

Use of the OHV system to perform an operative hysteroscopy by vaporization of the fibroid.

Group Type: EXPERIMENTAL

OHR VS OHV

Intervention Type: PROCEDURE

Control group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid.

Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid.

Interventions

OHR VS OHV

Control group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid.

Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient at least 18 years old.
• Non-pregnant patient
• A patient who had an ultrasound confirming the presence of a uterine fibroid to be treated less than 6 cm.
• Patient who had a diagnostic hysteroscopy confirming the presence of a uterine fibroid to be treated of type 0, 1 or 2 according to the FIGO classification.
• Patient presenting an indication for intra uterine fibroid resection (bleeding, fertility problems) by operative hysteroscopy.
• Patient having agreed to participate in the study and having signed an informed consent.

Exclusion Criteria

• Minor patient
• Patient not affiliated to a social security system
• Persons benefiting from special protection: by virtue of articles L1121-5 to L1121-8 of the Public Health Code: pregnant or breast-feeding women, minors, adults under guardianship or curatorship, persons deprived of liberty.
• Patient refusing to sign the consent or unable to receive the information necessary to give informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François CREMIEUX, Director

Role: STUDY_DIRECTOR

AP-HM

Locations

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-Rhone, France

Site Status: RECRUITING

Countries

France

Central Contacts

Aubert Agostini, MD/PhD

Role: CONTACT

aubert.agostini@ap-hm.fr

04 91 38 37 87 ext. +33

Facility Contacts

Marjorie Saccone

Role: primary

marjorie.saccone@ap-hm.fr

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

2021-09

Identifier Type: -

Identifier Source: org_study_id