An observational study in Cervical Cancers, Vaginal Cancers and Vulvar Cancers, sponsored by Tampere University Hospital. Enrolling by invitation at 1 site in Finland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Tampere University Hospital · Observational
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.
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 21 is below the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.
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Patients who underwent pelvic exenteration for gynecologic cancer at Tampere University Hospital on or after January 1, 2000
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Exclusion Criteria:
Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire
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.
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
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).
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
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.
Time frame: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
Plan to share: Undecided
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