Clinical trial NCT05264337: Lymphedema After Urologic Surgery
Official title: Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Bladder Neoplasms
Prostatic Neoplasms
Testicular Neoplasms
Penile Cancer
Keywords: Lymphedema
Lymph Node Excision
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-03-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing urologic surgery that includes lymph node dissection

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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing urologic surgery with lymph node dissection

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of patients with self-reported lymphedema at 12 months
timeFrame: 12 months after surgery
measure: Number of patients with self-reported lymphedema at 24 months
timeFrame: 24 months after surgery
measure: Change in tissue water content measured by MoistureMeterD Compact at 12 months
timeFrame: 12 months after surgery
measure: Change in tissue water content measured by MoistureMeterD Compact at 24 months
timeFrame: 24 months after surgery
measure: Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months
timeFrame: 12 months after surgery
measure: Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Number of patients with self-reported lymphedema at 1 month
timeFrame: 1 month after surgery
measure: Number of patients with self-reported lymphedema at 3 months
timeFrame: 3 months after surgery
measure: Number of patients with self-reported lymphedema at 6 months
timeFrame: 6 months after surgery
measure: Change in tissue water content measured by MoistureMeterD Compact at 1 month
timeFrame: 1 month after surgery
measure: Change in tissue water content measured by MoistureMeterD Compact at 3 months
timeFrame: 3 months after surgery
measure: Change in tissue water content measured by MoistureMeterD Compact at 6 months
timeFrame: 6 months after surgery
measure: Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month
timeFrame: 1 month after surgery
measure: Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month
timeFrame: 3 month after surgery
measure: Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month
timeFrame: 6 month after surgery
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Gothenburg University
name: Henrik Kjölhede, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: