Lymphatic Injury Visualization in Vascular Surgery (LymphFistula-P)

University Hospital Basel

Status: Not yet enrolling

Conditions: Pseudoaneurysm; Aneurysm; Vascular Surgical Procedure; Acute Ischemia; Peripheral Arterial Disease(PAD); Hemmorhage

Treatments: Procedure: Visualization of lymphatic injury and treatment of injury (in case of detection)

Study type: Interventional

Funder types: Other

Identifiers

NCT07499206

GCH-008_LymphFistula-Pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Visualization of lymphatic injury

Experimental group

Treatment:

Procedure: Visualization of lymphatic injury and treatment of injury (in case of detection)