- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594327
Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer
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
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Tampere, Finland
- Tampere University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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.
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Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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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
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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).
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Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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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
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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.
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Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Vulvar Diseases
- Vaginal Diseases
- Behavior
- Sexual Behavior
- Uterine Cervical Neoplasms
- Endometrial Neoplasms
- Vulvar Neoplasms
- Vaginal Neoplasms
- Sexuality
Other Study ID Numbers
- R25065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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