Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)
Monocentric Prospective Observational Multiparametric Study on the Quality of Life in Patients Undergone Surgery for Vulvar Cancer and Reconstruction (3233)
1 other identifier
observational
93
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2020
CompletedFirst Submitted
Initial submission to the registry
March 11, 2023
CompletedFirst Posted
Study publicly available on registry
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
November 15, 2023
November 1, 2023
6 years
March 11, 2023
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rand 36
Changes in RAND-36 score before and after surgery
June 2020 - June 2025
Secondary Outcomes (4)
ICIQ-SF
June 2020 - June 2025
FSFI
June 2020 - June 2025
ECOG
June 2020 - June 2025
LYM-LEG-QoL
June 2020 - June 2025
Study Arms (2)
Patients operated for vulvar cancer without reconstruction
Patients operated for vulvar cancer with reconstruction
Interventions
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
Patients undergoing ablative surgery for vulvar cancer associated or not to vulvoperineal reconstruction
You may qualify if:
- Patients undergoing surgery for vulvar cancer
- Patients providing consent to be enrolled in the study
You may not qualify if:
- Cognitive impairment
- psychiatric disorder
- neurodegenerative disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Related Publications (9)
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.
PMID: 23335087RESULTRajaram S, Gupta B. Management of Vulvar Cancer. Rev Recent Clin Trials. 2015;10(4):282-8. doi: 10.2174/1574887110666150923112723.
PMID: 26411953RESULTHellinga 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.
PMID: 30157166RESULTDessole 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.
PMID: 26807639RESULTFroeding 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.
PMID: 29420364RESULTSaimanen 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.
PMID: 31177131RESULTGentileschi 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.
PMID: 27550406RESULTGentileschi 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.
PMID: 34866009RESULTCaretto 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.
PMID: 35205824RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano Gentileschi, Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2023
First Posted
November 15, 2023
Study Start
June 23, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
November 15, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share