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Enrolling by Invitation

NCT Number: NCT07594327

Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer

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.

Enrolling by Invitation

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. 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

    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).

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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