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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical Cystectomy | Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer |
| |
| Radical Prostatectomy | Patients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer |
| |
| Retroperitoneal | Patients undergoing retroperitoneal lymph node dissection for testicular cancer |
| |
| Other | Patients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-reported lymphedema | Other | Lymphedema as reported by LymQOL questionnaire. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of patients with self-reported lymphedema at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing urologic surgery that includes lymph node dissection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henrik Kjölhede, MD, PhD | Contact | +46-31-3421000 | henrik.kjolhede@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Henrik Kjölhede, MD, PhD | Sahlgrenska University Hospital, Gothenburg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 41345 | Sweden |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D011471 | Prostatic Neoplasms |
| D013736 | Testicular Neoplasms |
| D010412 | Penile Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Dielectric constant ratio | Other | Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D. |
|
| Limb volume | Other | Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference. |
|
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
| 3 months after surgery |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Örebro University Hospital | Recruiting | Örebro | Sweden |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D010409 | Penile Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |