Clinical trial NCT05078307: Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
Official title: Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Fibroids
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Operative time
timeFrame: Baseline
Secondary outcomes:
measure: The amount of distention fluid used during operative hysteroscopy
timeFrame: Baseline
measure: Resection time
timeFrame: Baseline
measure: Complication rate during operative hysteroscopy
timeFrame: Baseline
measure: The rate of discontinuation of the operative hysteroscopy before complete resection
timeFrame: Baseline
measure: The rate of postoperative synechiae in patients of childbearing age.
timeFrame: between 6 and 8 weeks after the operation
measure: Operative pain
timeFrame: Baseline
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux Marseille
state: Bouches-du-Rhone
Study officials:
affiliation: AP-HM
name: François CREMIEUX, Director
role: STUDY_DIRECTOR
References: