ClinicalTrials.gg
RecruitingNCT05264337Updated Jan 16, 2026

Lymphedema After Urologic Surgery

An observational study in Urinary Bladder Neoplasms, Prostatic Neoplasms and Testicular Neoplasms, sponsored by Vastra Gotaland Region. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Vastra Gotaland Region · Observational

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Urinary Bladder Neoplasms with a site in Sweden — 7 open to participants now, 10 under way, 4 of them phase 3. Urinary Bladder Neoplasms · Sweden.

Started
2022
the only one that year
Observational
4 of 28
3 open now
Registered
18th of 28
by date
Lead sponsor
2 of 28
Vastra Gotaland Region

Among the 28 studies in Urinary Bladder Neoplasms with a site in Sweden, this one is the only one that started in 2022, is one of 4 observational ones, and was the 18th registered.

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

Browse Urinary Bladder Neoplasms studies →

Open to participants now

7 of the 28 studies in Urinary Bladder Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 28 studies in Urinary Bladder Neoplasms with a site in Sweden, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Urinary Bladder Neoplasms
  • Prostatic Neoplasms
  • Testicular Neoplasms
  • Penile Cancer

Keywords

  • Lymphedema
  • Lymph Node Excision
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing urologic surgery that includes lymph node dissection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing urologic surgery with lymph node dissection

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Radical Cystectomy

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

    Other: Self-reported lymphedema · Other: Dielectric constant ratio · Other: 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

  • OtherSelf-reported lymphedema

    Lymphedema as reported by LymQOL questionnaire.

  • OtherDielectric constant ratio

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

  • OtherLimb volume

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

06

What researchers measure

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 surgery

  2. 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 surgery

  3. 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 surgery

  4. 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 surgery

  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

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

    Time frame: 1 month after surgery

  2. 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 surgery

  3. 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 surgery

  4. 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 surgery

  5. 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

    Time frame: 3 months after surgery

  6. 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

    Time frame: 6 months after surgery

  7. 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.

    Time frame: 1 month after surgery

  8. 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.

    Time frame: 3 month after surgery

  9. 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.

    Time frame: 6 month after surgery

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2022 (actual). Primary completion is estimated for Jan 2027, 58 months after the start.

Of 167 non-industry observational studies under Urinary Bladder Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30. This study's planned 58 months is close to that.

Counting every sponsor, half of 202 studies reached it within 60 months; a quarter within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2022
First posted
Mar 3, 2022
StartActual
Mar 14, 2022
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2030
Last update
Jan 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05264337
Responsible party
Sponsor
First posted
Mar 3, 2022
Start date
Mar 14, 2022
Primary completion
Jan 2027 (estimated)
Completion
Jan 2030 (estimated)
Last update
Jan 16, 2026

Study contacts

Henrik Kjölhede, MD, PhD
Contact
henrik.kjolhede@vgregion.se
+46-31-3421000
Henrik Kjölhede, MD, PhD
principal investigator · Sahlgrenska University Hospital, Gothenburg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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