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RecruitingNCT07889856Updated Oct 22, 2026

Use of Reconstructive Microsurgery for the Treatment of Lymphedema

An observational study in Lymphedema, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study summary

Lymphedema is a chronic condition characterized by the accumulation of lymphatic fluid in tissues, frequently resulting from oncological treatments, trauma, or cancer. This condition causes significant functional impairment and severely impacts patients' quality of life, requiring complex and multidisciplinary therapeutic approaches.

In recent years, reconstructive microsurgery has played an increasingly important role in lymphedema treatment due to high-precision technologies. The use of ultra-high magnification operating microscopes allows the visualization of sub-millimetric vascular structures, enabling lymphatic-venous anastomoses and lymph node transfers on extremely small vessels (0.3-0.5 mm). Additionally, advanced intraoperative imaging, such as indocyanine green fluorescence, allows real-time identification of lymphatic vessels and patency assessment, improving surgical accuracy and clinical outcomes.

While recent experience shows high procedural success rates, a retrospective and systematic analysis of clinical data is necessary to structuredly evaluate functional outcomes. Therefore, this retrospective study aims to analyze the clinical experience gained to define the role of advanced microsurgical technologies in optimizing the therapeutic pathway for patients with lymphedema

02

Conditions studied

  • Lymphedema

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Keywords

  • Secondary Lymphedema
  • Reconstructive Microsurgery
  • Supermicrosurgery
  • Lymphaticovenous Anastomosis
03

In context

Lymphedema

569 studies on the registry are indexed under Lymphedema; 136 are open to participants now.

This study's planned enrollment of 15 is below the median of 108 across 147 observational studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Study population

Adult patients undergoing reconstructive microsurgery with lymphatic-venous anastomosis;

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

  • Age 18 years and older (male and female);
  • Patients undergoing reconstructive microsurgery with lymphatic-venous anastomosis;
  • Surgical procedure performed between January 1, 2024, and December 31, 2025;
  • Minimum follow-up period of 6 months.

Exclusion criteria

Exclusion Criteria:

  • Absence of one or more inclusion criteria.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients

    all adult patients with lymphedema treated in Istituto Ortopedico Rizzoli

    Procedure: Surgery with and without the aid of Indocyanine Green (ICG)

Interventions

  • ProcedureSurgery with and without the aid of Indocyanine Green (ICG)

    Microsurgical treatment for Lymphedema

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What researchers measure

Primary outcomes

  1. Change in limb volume

    Lymphedema improvement evaluated through the reduction of the volume of the treated limb compared to the preoperative baseline value.

    Time frame: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively

  2. Change in limb circumference

    Lymphedema improvement evaluated through the reduction of the circumference of the treated limb compared to the preoperative baseline value.

    Time frame: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively

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Study locations

1 of 1 sites recruiting
  • IRCCS Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07889856
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Sep 29, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Francesco Mori
Contact
francesco.mori@ior.it
MD

Oversight

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

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