In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids
NCT ID: NCT05604001
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-01-01
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Symptomatic submucosal myoma
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma.
hysteroscopic ablation of submucous uterine fibroid using diode laser
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma
Interventions
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hysteroscopic ablation of submucous uterine fibroid using diode laser
patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma
Eligibility Criteria
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Inclusion Criteria
* grade 0-2 (FIGO classification) ≤ 7cm fibroids with evident vascularity seen by 3D-DS compared to its adjacent myometrial tissue
Exclusion Criteria
* \>2 submucosal fibroids,
* pelvic inflammatory disease,
* known gynecologic malignancy,
* severe cervical stenosis,
* pregnancy
* desire of future fertility,
* previous cervical surgery
18 Years
50 Years
FEMALE
Yes
Sponsors
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Ariel University
OTHER
Responsible Party
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Sergio Haimovich
Director of the Gynecology Department at the Laniado Hospital
Principal Investigators
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Sergio Haimovich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Laniado University Hospital - Ariel University
Locations
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Laniado University Hospital
Netanya, , Israel
University of Cagliari
Cagliari, , Italy
universita della campagna luigi Vanvitelli
Napoli, , Italy
Parc de Salut Mar
Barcelona, , Spain
Countries
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References
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Carranza-Mamane B, Havelock J, Hemmings R; REPRODUCTIVE ENDOCRINOLOGY AND INFERTILITY COMMITTEE; SPECIAL CONTRIBUTOR. The management of uterine fibroids in women with otherwise unexplained infertility. J Obstet Gynaecol Can. 2015 Mar;37(3):277-285. doi: 10.1016/S1701-2163(15)30318-2.
Valentine LN, Bradley LD. Hysteroscopy for Abnormal Uterine Bleeding and Fibroids. Clin Obstet Gynecol. 2017 Jun;60(2):231-244. doi: 10.1097/GRF.0000000000000287.
Capmas P, Levaillant JM, Fernandez H. Surgical techniques and outcome in the management of submucous fibroids. Curr Opin Obstet Gynecol. 2013 Aug;25(4):332-8. doi: 10.1097/GCO.0b013e3283630e10.
Yendru KS, Yelamanchi SD, Vaddiraju GB. Hysteroscopic Resection of Submucous Fibroids in Symptomatic Women. J Obstet Gynaecol India. 2019 Apr;69(2):166-172. doi: 10.1007/s13224-018-1139-z. Epub 2018 May 31.
Vitale SG, Lagana AS, Caruso S, Garzon S, Vecchio GM, La Rosa VL, Casarin J, Ghezzi F. Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial. Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4.
Nappi L, Pontis A, Sorrentino F, Greco P, Angioni S. Hysteroscopic metroplasty for the septate uterus with diode laser: a pilot study. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:32-35. doi: 10.1016/j.ejogrb.2016.08.035. Epub 2016 Aug 31.
Haimovich S, Lopez-Yarto M, Urresta Avila J, Saavedra Tascon A, Hernandez JL, Carreras Collado R. Office Hysteroscopic Laser Enucleation of Submucous Myomas without Mass Extraction: A Case Series Study. Biomed Res Int. 2015;2015:905204. doi: 10.1155/2015/905204. Epub 2015 May 18.
Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.
Donnez J, Squifflet J, Polet R, Nisolle M. Laparoscopic myolysis. Hum Reprod Update. 2000 Nov-Dec;6(6):609-13. doi: 10.1093/humupd/6.6.609.
Dubuisson JB, Chapron C, Fauconnier A, Kreiker G. Laparoscopic myomectomy and myolysis. Curr Opin Obstet Gynecol. 1997 Aug;9(4):233-8.
D'Alterio MN, Scicchitano F, Fanni D, Faa G, Laganà AS, Noventa M, et al. Ex vivo myolysis with dual wavelengths diode laser system: macroscopic and histopathological examination. CEOG. 2021;48(4):875-82
Nieuwenhuis LL, Hehenkamp WJK, Brolmann HAM, Huirne JAF. 3D power Doppler in uterine fibroids; influence of gain, cardiac cycle and off-line measurement techniques. J Obstet Gynaecol. 2018 Jan;38(1):103-109. doi: 10.1080/01443615.2017.1330323. Epub 2017 Aug 7.
Vitale SG, Lagana AS, Torok P, Lasmar RB, Carugno J, Palumbo M, Tesarik J. Virtual sonographic hysteroscopy in assisted reproduction: A retrospective cost-effectiveness analysis. Int J Gynaecol Obstet. 2022 Jan;156(1):112-118. doi: 10.1002/ijgo.13651. Epub 2021 Mar 16.
Fleischer AC. Sonographic depiction of tumor vascularity and flow: from in vivo models to clinical applications. J Ultrasound Med. 2000 Jan;19(1):55-61. doi: 10.7863/jum.2000.19.1.55.
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
Munro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22.
Carugno J, Grimbizis G, Franchini M, Alonso L, Bradley L, Campo R, Catena U, Carlo A, Attilio DSS, Martin F, Haimovich S, Isaacson K, Moawad N, Saridogan E, Clark TJ. International Consensus Statement for Recommended Terminology Describing Hysteroscopic Procedures. J Minim Invasive Gynecol. 2022 Mar;29(3):385-391. doi: 10.1016/j.jmig.2021.10.004. Epub 2021 Oct 12.
Bettocchi S, Selvaggi L. A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Feb;4(2):255-8. doi: 10.1016/s1074-3804(97)80019-9.
Tinelli R, Litta P, Angioni S, Bettocchi S, Fusco A, Leo L, Landi S, Cicinelli E. A multicenter study comparing surgical outcomes and ultrasonographic evaluation of scarring after laparoscopic myomectomy with conventional versus barbed sutures. Int J Gynaecol Obstet. 2016 Jul;134(1):18-21. doi: 10.1016/j.ijgo.2015.10.029. Epub 2016 Mar 31.
Vitale SG, Riemma G, Haimovich S, Carugno J, Alonso Pacheco L, Perez-Medina T, Parry JP, Torok P, Tesarik J, Della Corte L, Cobellis L, Di Spiezio Sardo A, De Franciscis P. Risk of endometrial cancer in asymptomatic postmenopausal women in relation to ultrasonographic endometrial thickness: systematic review and diagnostic test accuracy meta-analysis. Am J Obstet Gynecol. 2023 Jan;228(1):22-35.e2. doi: 10.1016/j.ajog.2022.07.043. Epub 2022 Aug 4.
Georgiou D, Tranoulis A, Jackson TL. Hysteroscopic tissue removal system (MyoSure) for the resection of polyps, sub-mucosal leiomyomas and retained products of conception in an out-patient setting: A single UK institution experience. Eur J Obstet Gynecol Reprod Biol. 2018 Dec;231:147-151. doi: 10.1016/j.ejogrb.2018.10.030. Epub 2018 Oct 12.
Munro MG. Uterine polyps, adenomyosis, leiomyomas, and endometrial receptivity. Fertil Steril. 2019 Apr;111(4):629-640. doi: 10.1016/j.fertnstert.2019.02.008.
Vilos GA, Vilos AG, Abu-Rafea B, Leyland N, Allaire C, Laberge PY, Murji A, Singh SS, Thiel J. Interventional Uterine-Sparing Therapies for Leiomyomas: A Commentary on Myolysis. J Obstet Gynaecol Can. 2020 Feb;42(2):169-172. doi: 10.1016/j.jogc.2019.08.025. Epub 2019 Nov 23.
Other Identifiers
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LaMyA
Identifier Type: -
Identifier Source: org_study_id
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