Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer

May 19, 2026 updated by: 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.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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.
Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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