Lymphedema After Urologic Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Radical Cystectomy Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer |
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.
|
| Radical Prostatectomy Patients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer |
Other: Self-reported lymphedema
Lymphedema as reported by LymQOL questionnaire.
|
| Retroperitoneal Patients undergoing retroperitoneal lymph node dissection for testicular cancer |
Other: Self-reported lymphedema
Lymphedema as reported by LymQOL questionnaire.
|
| Other Patients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes |
Other: Self-reported lymphedema
Lymphedema as reported by LymQOL questionnaire.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Secondary Outcome Measures
- 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
- 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 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 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 6 month [6 month after surgery]
Measurements of circumference every 6 cm along the lower limbs.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients undergoing urologic surgery with lymph node dissection
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sahlgrenska University Hospital | Göteborg | Sweden | 41345 |
Sponsors and Collaborators
- Vastra Gotaland Region
Investigators
- Principal Investigator: Henrik Kjölhede, MD, PhD, Sahlgrenska University Hospital, Gothenburg University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-04840