Penile Cancer, Prostatic Neoplasms, Testicular Neoplasms, Urinary Bladder Neoplasms
Conditions
Keywords
Lymphedema, Lymph Node Excision
Brief summary
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
OTHERSelf-reported lymphedema
Lymphedema as reported by LymQOL questionnaire.
OTHERDielectric constant ratio
Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.
OTHERLimb volume
Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.
Sponsors
Vastra Gotaland Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing urologic surgery with lymph node dissection
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tissue water content measured by MoistureMeterD Compact at 12 months | 12 months after surgery | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact |
| Change in tissue water content measured by MoistureMeterD Compact at 24 months | 24 months after surgery | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact |
| Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months | 12 months after surgery | — |
| Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months | 24 months after surgery | — |
| Number of patients with self-reported lymphedema at 12 months | 12 months after surgery | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire |
| Number of patients with self-reported lymphedema at 24 months | 24 months after surgery | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in tissue water content measured by MoistureMeterD Compact at 6 months | 6 months after surgery | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact |
| Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month | 3 month after surgery | Measurements of circumference every 6 cm along the lower limbs. |
| Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month | 1 month after surgery | Measurements of circumference every 6 cm along the lower limbs. |
| Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month | 6 month after surgery | Measurements of circumference every 6 cm along the lower limbs. |
| Number of patients with self-reported lymphedema at 1 month | 1 month after surgery | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire |
| Number of patients with self-reported lymphedema at 3 months | 3 months after surgery | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire |
| Number of patients with self-reported lymphedema at 6 months | 6 months after surgery | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire |
| Change in tissue water content measured by MoistureMeterD Compact at 1 month | 1 month after surgery | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact |
| Change in tissue water content measured by MoistureMeterD Compact at 3 months | 3 months after surgery | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact |
Countries
Sweden
Contacts
CONTACTHenrik Kjölhede, MD, PhD
PRINCIPAL_INVESTIGATORHenrik Kjölhede, MD, PhD
Sahlgrenska University Hospital, Gothenburg University
Outcome results
None listed