Lymphedema After Urologic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Bladder Neoplasms, Prostatic Neoplasms, Testicular Neoplasms, Penile Cancer

Intervention / Treatment
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* Other: Self-reported lymphedema
* Other: Dielectric constant ratio
* Other: Limb volume


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing urologic surgery with lymph node dissection Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radical Cystectomy<br>Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer | Other: Self-reported lymphedema<br>* Lymphedema as reported by LymQOL questionnaire.<br>Other: Dielectric constant ratio<br>* Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.<br>Other: Limb volume<br>* Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.<br>|
| Radical Prostatectomy<br>Patients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer | Other: Self-reported lymphedema<br>* Lymphedema as reported by LymQOL questionnaire.<br>|
| Retroperitoneal<br>Patients undergoing retroperitoneal lymph node dissection for testicular cancer | Other: Self-reported lymphedema<br>* Lymphedema as reported by LymQOL questionnaire.<br>|
| Other<br>Patients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes | Other: Self-reported lymphedema<br>* Lymphedema as reported by LymQOL questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Lymph Node Excision