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

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Sep 30, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new method for treating uterine fibroids, which are non-cancerous growths in the uterus that can cause various issues like heavy bleeding or fertility problems. The study compares two techniques: one is the traditional method that involves cutting out the fibroids, and the other is a newer technique called vaporization, which uses heat to remove them. Researchers hope that the vaporization method will take less time to perform, which could mean fewer complications and make it possible to treat larger fibroids more effectively.

To participate in this trial, women must be at least 18 years old and have a confirmed diagnosis of a uterine fibroid that is less than 6 centimeters in size. They should also have symptoms that indicate they need treatment. Participants will be randomly assigned to one of the two treatment groups. Throughout the trial, researchers will monitor how long the procedures take and any side effects experienced afterwards. This study aims to enroll a total of 54 women over a span of two years, and it could lead to important advancements in treating women with fibroids.

Gender

FEMALE

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.