LymphedemaNCT07889856
Use of Reconstructive Microsurgery for the Treatment of Lymphedema
An observational study of Lymphedema, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Surgery with and without the aid of Indocyanine Green (ICG)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 29 Sep 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing reconstructive microsurgery with lymphatic-venous anastomosis;
Who may be able to join
- 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.
Who cannot join
- Absence of one or more inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Francesco Mori, MD, francesco.mori@ior.it
About this study
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
- Conditions
- Lymphedema
- Being tested
- Surgery with and without the aid of Indocyanine Green (ICG)
- Keywords
- Secondary Lymphedema, Reconstructive Microsurgery, Supermicrosurgery, Lymphaticovenous Anastomosis
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with and without the aid of Indocyanine Green (ICG)Procedure or surgery
Microsurgical treatment for Lymphedema
| Study group | Role | What they receive |
|---|---|---|
| patients | all adult patients with lymphedema treated in Istituto Ortopedico Rizzoli Receives: Procedure: Surgery with and without the aid of Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in limb volume
Lymphedema improvement evaluated through the reduction of the volume of the treated limb compared to the preoperative baseline value.
Measured: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively
Change in limb circumference
Lymphedema improvement evaluated through the reduction of the circumference of the treated limb compared to the preoperative baseline value.
Measured: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start29 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889856
- Sponsor's protocol ID
- Linf@IOR
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Reconstructive Microsurgery for the Treatment of Lymphedema
- ClinicalTrials.gov ID
- NCT07889856
- Acronym / sponsor ID
- Linf@IOR
- Conditions
- Lymphedema
- Keywords
- Secondary Lymphedema, Reconstructive Microsurgery, Supermicrosurgery, Lymphaticovenous Anastomosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: Surgery with and without the aid of Indocyanine Green (ICG)all adult patients with lymphedema treated in Istituto Ortopedico Rizzoli |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing reconstructive microsurgery with lymphatic-venous anastomosis;
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Absence of one or more inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery with and without the aid of Indocyanine Green (ICG)Microsurgical treatment for Lymphedema | Procedure or surgery | patients |
Primary outcome
Change in limb volume
Time frame: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively
Lymphedema improvement evaluated through the reduction of the volume of the treated limb compared to the preoperative baseline value.
Change in limb circumference
Time frame: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively
Lymphedema improvement evaluated through the reduction of the circumference of the treated limb compared to the preoperative baseline value.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Mori (MD, francesco.mori@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in limb volume (time frame: Preoperative (baseline), 7 days, 1 month, 3 months, and 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.