Lymphedema After Urologic Surgery

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264337
• Other study ID #: 2021-04840
• Status: Recruiting
• Start date: March 14, 2022
• Est. completion date: January 2030

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: Henrik Kjölhede, MD, PhD
• Phone: +46-31-3421000
• Email: henrik.kjolhede[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lymphedema
• Neoplasms
• Penile Cancer
• Penile Neoplasms
• Prostatic Neoplasms
• Testicular Neoplasms
• Urinary Bladder Neoplasms

Intervention

Other:
• Self-reported lymphedema
Lymphedema as reported by LymQOL questionnaire.
• Dielectric constant ratio
Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.
• Limb volume
Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

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