Lymphedema After Urologic Surgery

Recruiting

• Conditions: Urinary Bladder Neoplasms; Prostatic Neoplasms; Testicular Neoplasms; Penile Cancer
• Interventions: Other: Self-reported lymphedema; Other: Dielectric constant ratio; Other: Limb volume

• Registration Number: NCT05264337
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Study Start: 2022-03-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2027-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients undergoing urologic surgery with lymph node dissection

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radical Cystectomy	Self-reported lymphedema	Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer
Retroperitoneal	Self-reported lymphedema	Patients undergoing retroperitoneal lymph node dissection for testicular cancer
Radical Cystectomy	Dielectric constant ratio	Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer
Radical Cystectomy	Limb volume	Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer
Radical Prostatectomy	Self-reported lymphedema	Patients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer
Other	Self-reported lymphedema	Patients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 1 month	1 month 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 3 months	3 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.
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 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 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.

Trial Locations

Locations (2)

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Örebro University Hospital; 🇸🇪 Örebro, Sweden