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

Uterine Fibroids Clinical Trial

— VAPOHYSTERO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078307
• Other study ID #: 2021-09
• Secondary ID: IDRCB
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2021
• Est. completion date: May 17, 2024

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Aubert Agostini, MD/PhD
• Phone: 04 91 38 37 87
• Email: aubert.agostini[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 17, 2024
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux Marseille	Marseille	Bouches-du-Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time expressed in minutes	Baseline
Secondary	The amount of distention fluid used during operative hysteroscopy	Measured by collection of the distention fluid pockets at the end of the procedure	Baseline
Secondary	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
Secondary	Complication rate during operative hysteroscopy	Cervical tear rate and Rate of uterine perforations	Baseline
Secondary	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
Secondary	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
Secondary	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