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

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.

Study Overview

• Status: Recruiting
• Conditions: Uterine Fibroids
• Intervention / Treatment: Procedure: OHR VS OHV

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aubert Agostini, MD/PhD; Phone Number: +33 04 91 38 37 87; Email: aubert.agostini@ap-hm.fr

Study Locations

• France
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13354
      • Recruiting
      • Assistance Publique Hôpitaux Marseille
      • Contact: Marjorie Saccone; Email: marjorie.saccone@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OHR System; Use of the OHR system to perform an operative hysteroscopy by resection of the fibroid.	Procedure: 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.
Experimental: OHV System; Use of the OHV system to perform an operative hysteroscopy by vaporization of the fibroid.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time expressed in minutes	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of distention fluid used during operative hysteroscopy	Measured by collection of the distention fluid pockets at the end of the procedure	Baseline
Resection time	Time estimated in cm3/min based on ultrasound measurement of the volume of the myoma involved in the resection preoperatively and postoperatively, related to the operative time	Baseline
Complication rate during operative hysteroscopy	Cervical tear rate and Rate of uterine perforations	Baseline
The rate of discontinuation of the operative hysteroscopy before complete resection	Rate of discontinuation because of uterine perforations, operative time greater than 60 minutes, quantity of distension fluid greater than 9 liters, deficit of distension fluid greater than 1 liter, per operative haemorrhage	Baseline
The rate of postoperative synechiae in patients of childbearing age.	Rate of postoperative synechiae diagnosed at follow-up hysteroscopy in patients of childbearing age.	between 6 and 8 weeks after the operation
Operative pain	Operative pain evaluated by a visual analog scale (0-100mm). If the patient has a score of 0, it means that he/she has no pain. The higher the value, the more intense the pain.	Baseline

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, Director, AP-HM

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2021
• Primary Completion (Estimated): November 17, 2023
• Study Completion (Estimated): May 17, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: 2021-09; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No