Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)

Vulvar Neoplasms Clinical Trial

Official title:

Monocentric Prospective Observational Multiparametric Study on the Quality of Life in Patients Undergone Surgery for Vulvar Cancer and Reconstruction (3233)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132321
• Other study ID #: 3233
• Status: Recruiting
• Start date: June 23, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefano Gentileschi, Prof.
• Phone: +390630151
• Email: stefano.gentileschi[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the patients'quality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing surgery for vulvar cancer

• Patients providing consent to be enrolled in the study

Exclusion Criteria:

• Cognitive impairment

• psychiatric disorder

• neurodegenerative disorder

Related Conditions & MeSH terms

• Vulvar Neoplasms

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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 Fe — View Citation

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 — View Citation

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. A — View Citation

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 canc — View Citation

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. — View Citation

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.0 — View Citation

Rajaram S, Gupta B. Management of Vulvar Cancer. Rev Recent Clin Trials. 2015;10(4):282-8. doi: 10.2174/1574887110666150923112723. — View Citation

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: 10.21 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rand 36	Changes in RAND-36 score before and after surgery	June 2020 - June 2025
Secondary	ICIQ-SF	Changes in ICIQ-SF score before and after surgery	June 2020 - June 2025
Secondary	FSFI	Changes in FSFI score before and after surgery	June 2020 - June 2025
Secondary	ECOG	Changes in ECOG score before and after surgery	June 2020 - June 2025
Secondary	LYM-LEG-QoL	Changes in LYM-LEG-QoL score before and after surgery	June 2020 - June 2025