Prostatic Neoplasms Clinical Trial
Official title:
Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection
NCT number | NCT05264337 |
Other study ID # | 2021-04840 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 14, 2022 |
Est. completion date | January 2030 |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | January 2030 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients undergoing urologic surgery with lymph node dissection Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Göteborg | |
Sweden | Örebro University Hospital | Örebro |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with self-reported lymphedema at 12 months | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire | 12 months after surgery | |
Primary | Number of patients with self-reported lymphedema at 24 months | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire | 24 months after surgery | |
Primary | Change in tissue water content measured by MoistureMeterD Compact at 12 months | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact | 12 months after surgery | |
Primary | Change in tissue water content measured by MoistureMeterD Compact at 24 months | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact | 24 months after surgery | |
Primary | Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months | 12 months after surgery | ||
Primary | Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months | 24 months after surgery | ||
Secondary | Number of patients with self-reported lymphedema at 1 month | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire | 1 month after surgery | |
Secondary | Number of patients with self-reported lymphedema at 3 months | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire | 3 months after surgery | |
Secondary | Number of patients with self-reported lymphedema at 6 months | Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire | 6 months after surgery | |
Secondary | Change in tissue water content measured by MoistureMeterD Compact at 1 month | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact | 1 month after surgery | |
Secondary | Change in tissue water content measured by MoistureMeterD Compact at 3 months | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact | 3 months after surgery | |
Secondary | Change in tissue water content measured by MoistureMeterD Compact at 6 months | Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact | 6 months after surgery | |
Secondary | Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month | Measurements of circumference every 6 cm along the lower limbs. | 1 month after surgery | |
Secondary | Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month | Measurements of circumference every 6 cm along the lower limbs. | 3 month after surgery | |
Secondary | Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month | Measurements of circumference every 6 cm along the lower limbs. | 6 month after surgery |
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