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

NCT05078307 | Unknown

• 2 other identifiers: 2021-09IDRCB
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Operative time

  Operative time expressed in minutes

  Baseline

Secondary Outcomes (6)

• The amount of distention fluid used during operative hysteroscopy

  Baseline

• Resection time

  Baseline

• Complication rate during operative hysteroscopy

  Baseline

• The rate of discontinuation of the operative hysteroscopy before complete resection

  Baseline

• The rate of postoperative synechiae in patients of childbearing age.

  between 6 and 8 weeks after the operation

Study Arms (2)

OHR System

ACTIVE COMPARATOR

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

Procedure: OHR VS OHV

OHV System

EXPERIMENTAL

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

Procedure: OHR VS OHV

Interventions

OHR VS OHV 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.

OHR System; OHV System

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux Marseille

Marseille, Bouches-du-Rhone, 13354, France

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• François CREMIEUX, Director

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Aubert Agostini, MD/PhD

CONTACT

04 91 38 37 87; aubert.agostini@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 14, 2021
• Study Start: September 25, 2021
• Primary Completion: November 17, 2023
• Study Completion: May 17, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)