Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)
NCT ID: NCT06132321
Last Updated: 2023-11-15
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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RECRUITING
93 participants
OBSERVATIONAL
2020-06-23
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients operated for vulvar cancer without reconstruction
Quality of life questionnaires
Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction
Patients operated for vulvar cancer with reconstruction
Quality of life questionnaires
Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction
Interventions
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Quality of life questionnaires
Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction
Eligibility Criteria
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Inclusion Criteria
* Patients providing consent to be enrolled in the study
Exclusion Criteria
* psychiatric disorder
* neurodegenerative disorder
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Gentileschi Stefano
Associate Professor
Principal Investigators
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Stefano Gentileschi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
Rajaram S, Gupta B. Management of Vulvar Cancer. Rev Recent Clin Trials. 2015;10(4):282-8. doi: 10.2174/1574887110666150923112723.
Hellinga J, Te Grootenhuis NC, Werker PMN, de Bock GH, van der Zee AGJ, Oonk MHM, Stenekes MW. Quality of Life and Sexual Functioning After Vulvar Reconstruction With the Lotus Petal Flap. Int J Gynecol Cancer. 2018 Nov;28(9):1728-1736. doi: 10.1097/IGC.0000000000001340.
Dessole M, Petrillo M, Lucidi A, Naldini A, Rossi M, De Iaco P, Marnitz S, Sehouli J, Scambia G, Chiantera V. Quality of Life in Women After Pelvic Exenteration for Gynecological Malignancies: A Multicentric Study. Int J Gynecol Cancer. 2018 Feb;28(2):267-273. doi: 10.1097/IGC.0000000000000612.
Froeding LP, Greimel E, Lanceley A, Oberguggenberger A, Schmalz C, Radisic VB, Nordin A, Galalaei R, Kuljanic K, Vistad I, Schnack TH, Jensen PT; European Organization of Research Treatment of Cancer Quality of Life Group the Gynecological Cancer group. Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review. Int J Gynecol Cancer. 2018 May;28(4):808-817. doi: 10.1097/IGC.0000000000001211.
Saimanen I, Kuosmanen V, Rahkola D, Selander T, Karkkainen J, Harju J, Aspinen S, Eskelinen M. RAND-36-Item Health Survey: A Comprehensive Test for Long-term Outcome and Health Status Following Surgery. Anticancer Res. 2019 Jun;39(6):2927-2933. doi: 10.21873/anticanres.13422.
Gentileschi S, Servillo M, Garganese G, Fragomeni S, De Bonis F, Scambia G, Salgarello M. Surgical therapy of vulvar cancer: how to choose the correct reconstruction? J Gynecol Oncol. 2016 Nov;27(6):e60. doi: 10.3802/jgo.2016.27.e60. Epub 2016 Jul 12.
Gentileschi S, Caretto AA, Servillo M, Stefanizzi G, Alberti C, Garganese G, Fragomeni SM, Federico A, Tagliaferri L, Moroni R, Scambia G. Feasibility, indications and complications of SCIP flap for reconstruction after extirpative surgery for vulvar cancer. J Plast Reconstr Aesthet Surg. 2022 Mar;75(3):1150-1157. doi: 10.1016/j.bjps.2021.11.005. Epub 2021 Nov 13.
Caretto AA, Stefanizzi G, Fragomeni SM, Federico A, Tagliaferri L, Lancellotta V, Scambia G, Gentileschi S. Lymphatic Function of the Lower Limb after Groin Dissection for Vulvar Cancer and Reconstruction with Lymphatic SCIP Flap. Cancers (Basel). 2022 Feb 21;14(4):1076. doi: 10.3390/cancers14041076.
Other Identifiers
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3233
Identifier Type: -
Identifier Source: org_study_id
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