Predictive factors in lymphedema surgery

The ppLVA study = perioperative predictive (factor) LVA study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN72662721

Enrollment

100

Registered

2022-03-07

Start date

2019-08-16

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphaticovenous anastomosis surgery on lymphedema patients Surgery

Interventions

Patients with lymphedema that are eligible for Lymphaticovenous anastomosis-surgery (LVA surgery) are recruited for the study, which is a retrospective observational study with a prospectively maintai

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ICG confirmed primary or secondary lymphedema assessed suitable for LVA surgery.

Exclusion criteria

Exclusion criteria: 1. Edema caused by other dysfunction. 2. Advanced Lymphedema with no visual lymph vessels on ICG imaging.

Design outcomes

Primary

Measure	Time frame
Clinical assessment is done by a physician and a lymph therapist pre- and post-operatively at 1, 6, 12 and 24 months to assess invalidity due to lymphedema, weight, nikotin status, number of infections, range of motion, skin problems, swelling, heaviness, pressure sensation, numbness, pitting edema and stage of lymphedema, and whether this is better, worse or unchanged after surgery. This is done through interview and clinical assessment. The lymph therapist will evaluate and take history of compression therapy and measure the volume outcome with tape measurements.	—

Measure

Time frame

Clinical assessment is done by a physician and a lymph therapist pre- and post-operatively at 1, 6, 12 and 24 months to assess invalidity due to lymphedema, weight, nikotin status, number of infections, range of motion, skin problems, swelling, heaviness, pressure sensation, numbness, pitting edema and stage of lymphedema, and whether this is better, worse or unchanged after surgery. This is done through interview and clinical assessment. The lymph therapist will evaluate and take history of compression therapy and measure the volume outcome with tape measurements.

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Secondary

Measure	Time frame
1. Bio-impedance is measured with a non-invasive measurement tool, and 2D and 3D photos will be taken at 1, 6, 12 and 24 months 2. An assessment with ICG-L is made by injecting a small amount of fluorescent dye into the dermal skin after local anesthesia pre-operatively and 12 months post-operatively. 3. Lymphoscintigraphy is done pre-operatively and at 12 months post-operatively, by injecting a small amount of radioactive substance into the dermis to assess the level of lymphedema at the nuclear medicine department. 4. Quality of life (EQ-5D and LyQLI), level of activity, and previous treatment of lymphedema questionnaires are completed at 1, 6, 12 and 24 months The data collected peri-operatively is registered by the surgeon directly after surgery, by filling out a peri-operative evaluation form for LVA-surgery, developed at the Uppsala University Hospital.	—

Measure

Time frame

1. Bio-impedance is measured with a non-invasive measurement tool, and 2D and 3D photos will be taken at 1, 6, 12 and 24 months 2. An assessment with ICG-L is made by injecting a small amount of fluorescent dye into the dermal skin after local anesthesia pre-operatively and 12 months post-operatively. 3. Lymphoscintigraphy is done pre-operatively and at 12 months post-operatively, by injecting a small amount of radioactive substance into the dermis to assess the level of lymphedema at the nuclear medicine department. 4. Quality of life (EQ-5D and LyQLI), level of activity, and previous treatment of lymphedema questionnaires are completed at 1, 6, 12 and 24 months The data collected peri-operatively is registered by the surgeon directly after surgery, by filling out a peri-operative evaluation form for LVA-surgery, developed at the Uppsala University Hospital.

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Countries

Netherlands, Sweden, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026