NCT07594327

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
May 2026Oct 2026

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 12, 2026

Last Update Submit

May 19, 2026

Conditions

Cervical CancersVaginal CancersVulvar CancersEndometrial CancerGynecologic Cancers

Keywords

Pelvic exenterationQuality of lifeSexuality

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale by birth
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • cognitive and/or neurological disease that affects physical functioning and may therefore influence sexual functioning or make it difficult to respond to the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsVaginal NeoplasmsVulvar NeoplasmsEndometrial NeoplasmsSexuality

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesVaginal DiseasesVulvar DiseasesSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

FI(1)