NCT05264337

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Mar 2022Jan 2030

First Submitted

Initial submission to the registry

February 3, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

February 3, 2022

Last Update Submit

January 15, 2026

Conditions

Urinary Bladder NeoplasmsProstatic NeoplasmsTesticular NeoplasmsPenile Cancer

Keywords

LymphedemaLymph Node Excision

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (9)

  • Number of patients with self-reported lymphedema at 1 month

    1 month after surgery

  • Number of patients with self-reported lymphedema at 3 months

    3 months after surgery

  • Number of patients with self-reported lymphedema at 6 months

    6 months after surgery

  • Change in tissue water content measured by MoistureMeterD Compact at 1 month

    1 month after surgery

  • Change in tissue water content measured by MoistureMeterD Compact at 3 months

    3 months after surgery

  • +4 more secondary outcomes

Study Arms (4)

Radical Cystectomy

Patients undergoing radical cystectomy with pelvic lymph node dissection for urinary bladder cancer

Other: Self-reported lymphedemaOther: Dielectric constant ratioOther: Limb volume

Radical Prostatectomy

Patients undergoing radical prostatectomy with pelvic lymph node dissection for prostate cancer

Other: Self-reported lymphedema

Retroperitoneal

Patients undergoing retroperitoneal lymph node dissection for testicular cancer

Other: Self-reported lymphedema

Other

Patients undergoing other urologic surgery with lymph node dissection of inguinal, iliacal or retroperitoneal lymph nodes

Other: Self-reported lymphedema

Interventions

Dielectric constant ratioOTHER

Measurement of percentage tissue water content of lower extremities by dielectric constant ratio measured by MoistureMeter D.

Radical Cystectomy
Limb volumeOTHER

Measurement of lymphedema by limb volume of lower extremities by multiple measurements of circumference.

Radical Cystectomy
Self-reported lymphedemaOTHER

Lymphedema as reported by LymQOL questionnaire.

OtherRadical CystectomyRadical ProstatectomyRetroperitoneal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing urologic surgery that includes lymph node dissection

You may qualify if:

  • Patients undergoing urologic surgery with lymph node dissection

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Örebro University Hospital

Örebro, Sweden

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsProstatic NeoplasmsTesticular NeoplasmsPenile NeoplasmsLymphedema

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesEndocrine Gland NeoplasmsEndocrine System DiseasesTesticular DiseasesGonadal DisordersPenile DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Henrik Kjölhede, MD, PhD

    Sahlgrenska University Hospital, Gothenburg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henrik Kjölhede, MD, PhD

CONTACT

+46-31-3421000henrik.kjolhede@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2022

First Posted

March 3, 2022

Study Start

March 14, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2030

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)