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Recruiting NCT05264337

Lymphedema After Urologic Surgery

— Observational Urinary Bladder Neoplasms Prostatic Neoplasms Testicular Neoplasms Penile Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-reported lymphedema, Dielectric constant ratio, Limb volume.
Who it may be relevant to
Registry conditions: Urinary Bladder Neoplasms, Prostatic Neoplasms, Testicular Neoplasms, Penile Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection

Overview

Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.

Interventions

  • Other Self-reported lymphedema
    Lymphedema as reported by LymQOL questionnaire.
  • Other Dielectric constant ratio
    Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.
  • Other Limb volume
    Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.

Primary outcome measures

  • Number of patients with self-reported lymphedema at 12 months [Time frame: 12 months after surgery]
  • Number of patients with self-reported lymphedema at 24 months [Time frame: 24 months after surgery]
  • Change in tissue water content measured by MoistureMeterD Compact at 12 months [Time frame: 12 months after surgery]
  • Change in tissue water content measured by MoistureMeterD Compact at 24 months [Time frame: 24 months after surgery]
  • Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months [Time frame: 12 months after surgery]
  • Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months [Time frame: 24 months after surgery]
Secondary outcome measures (9)
  • Number of patients with self-reported lymphedema at 1 month [Time frame: 1 month after surgery]
  • Number of patients with self-reported lymphedema at 3 months [Time frame: 3 months after surgery]
  • Number of patients with self-reported lymphedema at 6 months [Time frame: 6 months after surgery]
  • Change in tissue water content measured by MoistureMeterD Compact at 1 month [Time frame: 1 month after surgery]
  • Change in tissue water content measured by MoistureMeterD Compact at 3 months [Time frame: 3 months after surgery]
  • Change in tissue water content measured by MoistureMeterD Compact at 6 months [Time frame: 6 months after surgery]
  • Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month [Time frame: 1 month after surgery]
  • Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month [Time frame: 3 month after surgery]
  • Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month [Time frame: 6 month after surgery]

Eligibility criteria

Inclusion criteria

  • Patients undergoing urologic surgery with lymph node dissection

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 2 centers
  • Sahlgrenska University Hospital — Gothenburg
  • Örebro University Hospital — Örebro

Identifiers

NCT: NCT05264337 · 2021-04840

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗