Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Tissue Adhesions

Myoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Asherman's Syndrome

For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure

HYALOBARRIER Gel

Jean-Louis Benifla, MD, PhD

The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.

Hysteroscopic myomectomy is the referent surgical treatment for submucous myoma. But intrauterine adhesion rate was evaluated about 7 to 15% after this procedure. The investigators hypothetically believe that application of HYALOBARRIER Gel at the end of the procedure, could be reduce the mean intrauterine rate to 50%. Thus, the investigators performed a multicenter (n = 20) prospective study non randomized in 220 patients with submucous myoma \< 3 cm of diameter, evaluated by preoperative ultrasound. The investigators prefer this study design, because the principal reason is the number of enrolled patient were more 200 patients in each group with a double blind randomized study. Now, in all patients, after hysteroscopic myomectomy which performed with a same technique in each center (bipolar coagulation and physiologic serum), a diagnostic hysteroscopy was performed at 2 month to determinate the existence of intrauterine adhesion. Secondary end points were in this study the tolerance and side effects of HYALOBARRIER Gel and the subsequent fertility at 2 years.

Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel

Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective Tissue

Connective Tissue Diseases

All Drugs and Chemicals

Reproductive Control Agents

Hormones

Ulipristal acetate

Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis

Transvaginal ultrasound

Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas

Anamnesis

Operative hysteroscopy allows a direct evaluation of number, size (diameter and volume), location and appearance of submucous uterine myomas. This exam allows the resection of the myomas.

Operative hysteroscopy

Simone Ferrero, MD, PhD

Simone Ferrero

Fabio Barra, MD

The aim of this observational retrospective analysis is to evaluate predictive factors for complete myoma resection during hysteroscopic myomectomy for developing and validating a nomogram.

This tool can help clinicians to support the patient in making an informed decision about therapeutic options for uterine submucous myomas by defining risk factors predicting a high complexity myomectomy.

Overall, 10% of all uterine myomas are submucosal. These myomas spread into the uterine cavity, lifting the endometrial mucosa, and are a common cause of abnormal uterine bleeding, dysmenorrhea, early miscarriage and they may be a cause of infertility.

Hysteroscopic myomectomy is the surgical procedure of choice for the treatment of submucosal myomas, because it is minimally invasive and has the advantage of preserving the integrity of the uterine wall.

The characteristics of the myomas (size, number and location) enables the surgeon to choose the surgical approach that will provide the best outcome for the patient, and may predict the chances of a complete hysteroscopic resection of myomas in one procedure.

Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy

A Retrospective Study for Developing a Nomogram for Predicting Change of Complete Myoma Resection During Hysteroscopic Myomectomy

Ospedale Policlinico San Martino

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel	NCT01412489	Myoma	HYALOBARRIER Ge...	18 Years - 45 Years	Assistance Publique - Hôpitaux de Paris
Predictive Factors for Complete Myoma Resection During Hysteroscopic Myomectomy	NCT04400942	Uterine Fibroid... Uterine Myomas	Transvaginal ul... Anamnesis Operative hyste...	18 Years -	Ospedale Policlinico San Martino
Intrauterine Adhesion Rate After Hysteroscopic Myomectomy and Application of HYALOBARRIER Gel	NCT01412489	Myoma	HYALOBARRIER Ge...	18 Years - 45 Years	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for operative hysteroscopy