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NCT Number: NCT05264337

Lymphedema After Urologic Surgery

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.

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Key information

Conditions

Urinary Bladder Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Male Urogenital Diseases Neoplasms Neoplasms by Site Penile Cancer Penile Diseases Penile Neoplasms Prostatic Diseases Prostatic Neoplasms Testicular Diseases Testicular Neoplasms Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing urologic surgery with lymph node dissection

Exclusion criteria

  • None

Treatment and study plan

Self-reported lymphedema

Other

Lymphedema as reported by LymQOL questionnaire.

Dielectric constant ratio

Other

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

Limb volume

Other

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

Primary outcomes

  1. Number of patients with self-reported lymphedema at 12 months

    Time frame: 12 months after surgery

    Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire

  2. Number of patients with self-reported lymphedema at 24 months

    Time frame: 24 months after surgery

    Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire

  3. Change in tissue water content measured by MoistureMeterD Compact at 12 months

    Time frame: 12 months after surgery

    Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact

  4. Change in tissue water content measured by MoistureMeterD Compact at 24 months

    Time frame: 24 months after surgery

    Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact

  5. Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months

    Time frame: 12 months after surgery

  6. Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months

    Time frame: 24 months after surgery

Secondary outcomes

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

    Time frame: 1 month after surgery

    Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire

  2. Number of patients with self-reported lymphedema at 3 months

    Time frame: 3 months after surgery

    Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire

  3. Number of patients with self-reported lymphedema at 6 months

    Time frame: 6 months after surgery

    Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire

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

    Time frame: 1 month after surgery

    Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact

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

    Time frame: 3 months after surgery

    Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact

  6. Change in tissue water content measured by MoistureMeterD Compact at 6 months

    Time frame: 6 months after surgery

    Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact

  7. Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month

    Time frame: 1 month after surgery

    Measurements of circumference every 6 cm along the lower limbs.

  8. Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month

    Time frame: 3 month after surgery

    Measurements of circumference every 6 cm along the lower limbs.

  9. Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month

    Time frame: 6 month after surgery

    Measurements of circumference every 6 cm along the lower limbs.

Study contacts

Contact information is provided by the study sponsor or research team.

Henrik Kjölhede, MD, PhD

CONTACT

[email protected]

+46-31-3421000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Mar 3, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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