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Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer

19. maj 2026 opdateret af: Tampere University Hospital

Pelvic Exenteration as a Curative Option in Recurrent Gynecological Cancer: Oncological Outcomes and Impact on Quality of Life and Sexuality

Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible.

The aim of this study is to examine the quality of life and sexuality of patients who have undergone pelvic exenteration.

This observational cross-sectional study utilizes internationally validated questionnaires assessing quality of life and sexual function: EORTC QLQ-C30, EORTC QLQ-CX24, and PISQ-12.

The findings of this study will provide important guidance for the selection and planning of pelvic exenteration. Improved understanding of postoperative quality of life will support patient selection and enable more comprehensive and individualized patient counseling.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Detaljeret beskrivelse

The investigators will invite living patients who have undergone pelvic exenteration for gynecological cancer at Tampere University Hospital since January 1, 2000, to participate in the study, provided that at least six months have elapsed since the surgery.

The patients are first contacted by telephone to inform them about the study. The investigators will then send an information letter regarding participation, along with questionnaires assessing quality of life and sexuality. There are 21 living patients, most of whom have had cervical cancer. Particular interest will be given to patients who have undergone neovaginal reconstruction, and additional sexuality-related questions have been developed specifically for these patients.

In addition, the medical records of all patients who have undergone pelvic exenteration for gynecological cancer since January 1, 2000, are retrospectively reviewed. Oncological outcomes after pelvic exenteration, factors affecting prognosis, and postoperative complications are assessed.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

21

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who underwent pelvic exenteration for gynecologic cancer at Tampere University Hospital on or after January 1, 2000

Beskrivelse

Inclusion Criteria:

  • patient age over 18 years
  • a diagnosis of gynecologic cancer
  • having undergone exenteration surgery on or after January 1, 2000 (at least 6 months prior)
  • the ability to read and write Finnish

Exclusion Criteria:

  • cognitive and/or neurological disease that affects physical functioning and may therefore influence sexual functioning or make it difficult to respond to the questionnaire

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire
Tidsramme: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
The EORTC QLQ-C30 is a 30-item questionnaire measuring the quality of life (QoL) of cancer patients, developed by the European Organisation for Research and Treatment of Cancer (EORTC). It assesses physical, psychological, and social functioning.
Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
Self-reporterd quality of life measured by EORTC QLQ-CX24 questionnaire
Tidsramme: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
The EORTC QLQ-CX24 is a 24-item questionnaire, designed to assess disease-specific and treatment-specific aspects of quality of life in patients with cervical cancer. It is developed by the European Organisation for Research and Treatment of Cancer (EORTC).
Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
Self-reported sexuality assessed by the PISQ-12 questionnaire with additional study-specific questions
Tidsramme: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
The PISQ-12 questionnaire is designed for patients with urinary incontinence or pelvic organ prolapse. However, it also includes useful questions for patients undergoing pelvic exenteration. In addition, the investigators have developed and included their own questions specifically tailored for patients with a neovagina.
Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tampere University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R25065

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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