Lymphedema After Urologic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Testicular Neoplasms; Prostatic Neoplasms; Urinary Bladder Neoplasms; Penile Cancer
• Intervention / Treatment: Other: Self-reported lymphedema; Other: Dielectric constant ratio; Other: Limb volume

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Henrik Kjölhede, MD, PhD; Phone Number: +46-31-3421000; Email: henrik.kjolhede@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Henrik Kjölhede, MD PhD; Phone Number: +46-31-3421000; Email: henrik.kjolhede@vgregion.se
  • Örebro, Sweden
    • Recruiting
    • Orebro University Hospital
    • Contact: Peter Kirrander, MD PhD; Email: peter.kirrander@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing urologic surgery that includes lymph node dissection

Description

Inclusion Criteria:

• Patients undergoing urologic surgery with lymph node dissection

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Henrik Kjölhede, MD, PhD, Sahlgrenska University Hospital, Gothenburg University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Lymphedema; Lymph Node Excision
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Endocrine Gland Neoplasms; Gonadal Disorders; Lymphatic Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Penile Diseases; Testicular Diseases; Hemic and Lymphatic Diseases; Prostatic Neoplasms; Lymphedema; Urinary Bladder Neoplasms; Penile Neoplasms; Testicular Neoplasms
• Other Study ID Numbers: 2021-04840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No