Lymphedema After Urologic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients undergoing urologic surgery with lymph node dissection
Disqualifiers
None
Trial population
All patients undergoing urologic surgery that includes lymph node dissection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Self-reported lymphedema
Other interventionLymphedema as reported by LymQOL questionnaire.
Dielectric constant ratio
Other interventionMeasurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.
Limb volume
Other interventionMeasurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Radical Cystectomy3 interventions
Group B: Radical Prostatectomy1 intervention
Group C: Retroperitoneal1 intervention
Group D: Other1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
12 months after surgery2
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
Time frame
24 months after surgery3
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
Time frame
12 months after surgery4
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
Time frame
24 months after surgerySecondary outcomes
1
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
Time frame
1 month after surgery2
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
Time frame
3 months after surgery3
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
Time frame
6 months after surgery4
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
Time frame
1 month after surgerySponsors and contacts
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Source ClinicalTrials.gov