Lymphatic Injury Visualization in Vascular Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Visualization of lymphatic injury and treatment of injury (in case of detection).
- Who it may be relevant to
- Registry conditions: Vascular Surgical Procedure, Peripheral Arterial Disease(PAD), Acute Ischemia, Hemmorhage. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Visualization and Treatment of Lymphatic Injury During Vascular Surgery Procedures in the Groin: A Pilot Study
Overview
This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.
Detailed description
Gaining arterial access in the groin is a very common surgical procedure for vascular surgeons. To reach the femoral artery, invisible lymphatic vessels are often harmed and in turn lymphatic injuries are created. Due to their transparent color and small size, these injuries remain unseen during surgery and are therefore untreated. These small lymphatic injuries can lead to wound complications including lymphoceles, lymphatic fistulas and surgical site infections (SSI) that are associated with higher morbidity and prolonged hospital stay, even mandating re-interventions in some cases.
The investigators hope to reduce wound complication rates by visualizing and directly treating these lymphatic injuries. To be able to detect the injuries, PatentBlau V (E131) will be applied, a blue dye with Swissmedic approval for visualization of lymphatic vessels. Sex differences will be noted and analyzed, gender as a dimension is not relevant.
Interventions
- Procedure Visualization of lymphatic injury and treatment of injury (in case of detection)
PatentBlau V application: 2ml will be injected intradermally around the groin wound. After allowing a maximum of 10 minutes for lymphatic uptake of the blue dye, a thorough inspection of the wound will be performed to detect possible lymphatic injuries, which will be visible by the blue color. Direct treatment (e.g. suture, clipping) of visible lymphatic injuries will be performed.
Primary outcome measures
- Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI) [Time frame: Up to 30 days postoperatively]
Secondary outcome measures (4)
- Intraoperative incidence of lymphatic injury [Time frame: Intraoperatively]
- Rate of re-interventions, defined as further invasive measure in the respective groin [Time frame: Up to 30 days postoperatively]
- Lenght of hospital stay [Time frame: Up to 30 days postoperatively]
- 30-day mortality [Time frame: Up to 30 days postoperatively]
Eligibility criteria
Inclusion criteria
- adult patients undergoing vascular surgery procedures in the groin
- signed informed consent for study participation
Exclusion criteria
- pregnant or lactating women
- prior groin surgery
- infected surgical site in the groin
- necessity for further incisions (e.g. bypass surgery)
- incapability of judgement or consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- University Hospital Basel — Basel
Identifiers
NCT: NCT07499206 · GCH-008_LymphFistula-Pilot