Uterine Fibroid Clinical Trial
— MyolysisOfficial title:
Office Preparation of Partially Intramural Uterine Myomas (OPPIuM) and Myolysis With Diode Laser Dual Wavelengths Laser System (DWLS) for the Treatment of G1-G2 Symptomatic Myomas
PURPOSE OF THE STUDY The study aims to examine the feasibility and effectiveness of the OPPIuM technique combined with myolysis using the DWLS diode laser. In addition, to evaluate the reduction of myoma volume and the extent of uterine bleeding with myolysis to improve women's quality of life and avoid resectoscope hysteroscopy for a G2 MIOMA, which may lead to an increase in intraoperative surgical risks and long-term complications. POPULATION 35 patients aged between 18 and 48 years with clinical and/or ultrasound diagnosis of uterine fibromatosis, belonging to the Endometriosis/Pelvic Chronic Pain Centre of the Complex Operating Unit of Gynecology of the University Polyclinic of Monserrato and other centers involved in the study. To be eligible for inclusion, patients with ultrasound and hysteroscopic diagnosis of a single submucosal myoma, partially intramural (G1 or G2) ≤ 3 cm, must present symptoms such as abnormal uterine bleeding and pelvic pain, for which surgical treatment was scheduled. INCLUSION CRITERIA - Women between 18 and 48 years old - Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding and/or pelvic pain) with single fibroma ≤ 3 cm G1 or G2. EXCLUSION CRITERIA Patients who cannot provide written informed consent or follow the procedures set out in the protocol. - Patients with malignant neoplasms or serious systemic diseases - Patients with multiple fibroids or single > 3 cm - Asymptomatic patients - Patients with other uterine or related diseases - Patients seeking a pregnancy. INTERVENTION STRATEGY AND INSTRUMENTS A total of 35 women will initially be included in the study, of which: Patients will undergo the following assessments: - Collection of physiological, pathological, and pharmacological anamnesis - Collection of diagnostic tests (ultrasound) and staging of the underlying disease (uterine fibromatosis) - Completion of the PBAC questionnaire - Transvaginal ultrasound - Office diagnostic hysteroscopy with OPPIuM and Myolysis - Possible resectoscope hysteroscopy or laser myomectomy in narcosis.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | January 1, 2022 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility | Inclusion Criteria: - Women between 18 and 48 years old - Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding, pelvic pain and/or infertility) with single fibroma = 3 cm G1 or G2. Exclusion Criteria: - Patients who are unable to provide written informed consent or to follow the procedures set out in the protocol. - Patients with malignant neoplasms or serious systemic diseases - Patients with multiple fibroids or single > 3 cm - Asymptomatic patients - Patients with other uterine or related diseases - Patients seeking for a pregnancy. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Cagliari,Obstetrics and Gynecological Department, | Monserrato | Cagliari |
Lead Sponsor | Collaborator |
---|---|
University of Cagliari | Azienda Ospedaliera Ordine Mauriziano di Torino, BelMedic Hospital, Beograd, Serbia, Civic Hospital, Italy, Clinical Hospital Center Rijeka, University of Foggia |
Italy,
Angioni S, Pontis A, Sorrentino F, Nappi L. Bilateral salpingo-oophorectomy and adhesiolysis with single port access laparoscopy and use of diode laser in a BRCA carrier. Eur J Gynaecol Oncol. 2015;36(4):479-81. — View Citation
Bettocchi S, Di Spiezio Sardo A, Ceci O, Nappi L, Guida M, Greco E, Pinto L, Camporiale AL, Nappi C. A new hysteroscopic technique for the preparation of partially intramural myomas in office setting (OPPIuM technique): A pilot study. J Minim Invasive Gynecol. 2009 Nov-Dec;16(6):748-54. doi: 10.1016/j.jmig.2009.07.016. — View Citation
Di Spiezio Sardo A, Mazzon I, Bramante S, Bettocchi S, Bifulco G, Guida M, Nappi C. Hysteroscopic myomectomy: a comprehensive review of surgical techniques. Hum Reprod Update. 2008 Mar-Apr;14(2):101-19. Epub 2007 Dec 6. Review. — View Citation
Haimovich S, Mancebo G, Alameda F, Agramunt S, Solé-Sedeno JM, Hernández JL, Carreras R. Feasibility of a new two-step procedure for office hysteroscopic resection of submucous myomas: results of a pilot study. Eur J Obstet Gynecol Reprod Biol. 2013 Jun;168(2):191-4. doi: 10.1016/j.ejogrb.2013.01.002. Epub 2013 Jan 31. — View Citation
Herman MC, Mak N, Geomini PM, Winkens B, Mol BW, Bongers MY; International Heavy Menstrual Bleeding IPD Meta-analysis Collaborative Group. Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study. BJOG. 2017 Jan;124(2):277-282. doi: 10.1111/1471-0528.14434. — View Citation
Nappi L, Sorrentino F, Angioni S, Pontis A, Litta P, Greco P. Feasibility of hysteroscopic endometrial polypectomy using a new dual wavelengths laser system (DWLS): preliminary results of a pilot study. Arch Gynecol Obstet. 2017 Jan;295(1):3-7. doi: 10.1007/s00404-016-4232-5. Epub 2016 Nov 11. — View Citation
Stewart EA. Uterine fibroids. Lancet. 2001 Jan 27;357(9252):293-8. Review. — View Citation
Zupi E, Sbracia M, Marconi D, Munro MG. Myolysis of uterine fibroids: is there a role? Clin Obstet Gynecol. 2006 Dec;49(4):821-33. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of symptoms decrease | Change from baseline in symptoms on PBAC score (Herman MC et al.) at 3 months | 3 months | |
Secondary | Evaluation of myoma volume reduction | Change from baseline in moyoma volume on ultrasound at 3 months | 3 months |
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