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Enrolling by invitation NCT07594327

Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer

— Observational Cervical Cancers Vaginal Cancers Vulvar Cancers Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Cancers, Vaginal Cancers, Vulvar Cancers, Endometrial Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire [Time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration]
  • Self-reporterd quality of life measured by EORTC QLQ-CX24 questionnaire [Time frame: 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 [Time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Finland · 1 center
  • Tampere University Hospital — Tampere

Identifiers

NCT: NCT07594327 · R25065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗