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RecruitingNCT06132321Updated Nov 15, 2023

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

An observational study in Vulvar Neoplasms, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2023-11-15.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
93
Sex
Female
01

Study 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.

02

Conditions studied

  • Vulvar Neoplasms

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Keywords

  • Vulvar Neoplasms
  • Vulvar cancer
  • Vulvar Reconstruction
  • Vulvoperineal Reconstruction
  • Gynecological Cancer
  • Quality of Life
03

In context

Vulvar Neoplasms

210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.

This study's planned enrollment of 93 is below the median of 148 across 51 observational studies indexed under Vulvar Neoplasms.

Browse Vulvar Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing ablative surgery for vulvar cancer associated or not to vulvoperineal reconstruction

Inclusion criteria

  • Patients undergoing surgery for vulvar cancer
  • Patients providing consent to be enrolled in the study

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment
  • psychiatric disorder
  • neurodegenerative disorder
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
93 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients operated for vulvar cancer without reconstruction

    Behavioral: Quality of life questionnaires

  • Patients operated for vulvar cancer with reconstruction

    Behavioral: Quality of life questionnaires

Interventions

  • BehavioralQuality 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

06

What researchers measure

Primary outcomes

  1. Rand 36

    Changes in RAND-36 score before and after surgery

    Time frame: June 2020 - June 2025

Secondary outcomes

  1. ICIQ-SF

    Changes in ICIQ-SF score before and after surgery

    Time frame: June 2020 - June 2025

  2. FSFI

    Changes in FSFI score before and after surgery

    Time frame: June 2020 - June 2025

  3. ECOG

    Changes in ECOG score before and after surgery

    Time frame: June 2020 - June 2025

  4. LYM-LEG-QoL

    Changes in LYM-LEG-QoL score before and after surgery

    Time frame: June 2020 - June 2025

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 23335087 ↗
  • Rajaram S, Gupta B. Management of Vulvar Cancer. Rev Recent Clin Trials. 2015;10(4):282-8. doi: 10.2174/1574887110666150923112723. PubMed 26411953 ↗
  • 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. Erratum In: Int J Gynecol Cancer. 2019 Sep;29(7):1230. doi: 10.1136/ijgc-2019-IGC.0000000000001340corr1. PubMed 30157166 ↗
  • 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. PubMed 26807639 ↗
  • 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. PubMed 29420364 ↗
  • 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. PubMed 31177131 ↗
  • 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. PubMed 27550406 ↗
  • 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. PubMed 34866009 ↗
  • 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. PubMed 35205824 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06132321
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Gentileschi Stefano (Associate Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Nov 15, 2023
Start date
Jun 23, 2020
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Nov 15, 2023

Study contacts

Stefano Gentileschi, Prof.
Contact
stefano.gentileschi@policlinicogemelli.it
+390630151
Anna Amelia Caretto, MD
Contact
carettoaa@gmail.com
+390630151
Stefano Gentileschi, Prof.
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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