OPPIuM Technique and Myolysis With Diode Laser Dwls

NCT04748978 | Unknown DMC

• 1 other identifier: OPPIuM MYOLYSIS DWLS
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Fibroid; Myoma;Uterus

Keywords

fibroid; myoma; hysteroscopy; diode laser

Outcome Measures

Primary Outcomes (1)

• Evaluation of symptoms decrease

  Change from baseline in symptoms on PBAC score (Herman MC et al.) at 3 months

  3 months

Secondary Outcomes (1)

• Evaluation of myoma volume reduction

  3 months

Study Arms (1)

symptomatic uterine fibroids

EXPERIMENTAL

patients aged between 18 and 48 years with clinical and/or ultrasound diagnosis of uterine fibromatosis

Procedure: hysteroscopy

Interventions

hysteroscopy PROCEDURE

OPPIum and Myolysis

Also known as: myolysis

symptomatic uterine fibroids

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: uterine fibroids
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cagliari: lead
• University of Foggia: collaborator
• Azienda Ospedaliera Ordine Mauriziano di Torino: collaborator
• Civic Hospital, Italy: collaborator
• Clinical Hospital Center Rijeka: collaborator
• BelMedic Hospital, Beograd, Serbia: collaborator

Study Sites (1)

University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, 09042, Italy

RECRUITING

Related Publications (8)

• Stewart EA. Uterine fibroids. Lancet. 2001 Jan 27;357(9252):293-8. doi: 10.1016/S0140-6736(00)03622-9.

  PMID: 11214143 BACKGROUND

• 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. doi: 10.1097/01.grf.0000211961.91616.78.

  PMID: 17082676 BACKGROUND

• 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.

  PMID: 19896603 BACKGROUND

• Haimovich S, Mancebo G, Alameda F, Agramunt S, Sole-Sedeno JM, Hernandez 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.

  PMID: 23375904 BACKGROUND

• 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.

  PMID: 26390708 BACKGROUND

• 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.

  PMID: 27834002 BACKGROUND

• 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.

  PMID: 28012272 BACKGROUND

• 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. doi: 10.1093/humupd/dmm041. Epub 2007 Dec 6.

  PMID: 18063608 BACKGROUND

MeSH Terms

Conditions

Leiomyoma; Myofibroma; Myoma

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Stefano Angioni, Prof

CONTACT

07051093399; sangioni@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 10, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

IT (1)