Lymphatic Injury Visualization in Vascular Surgery

Официальное название

Visualization and Treatment of Lymphatic Injury During Vascular Surgery Procedures in the Groin: A Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Composite endpoint: Number of participants with wound complications including lymphocele, lymphatic fistula, and surgical site infection (SSI) [Срок оценки: Up to 30 days postoperatively]

Вторичные конечные точки (4)

• Intraoperative incidence of lymphatic injury [Срок оценки: Intraoperatively]
• Rate of re-interventions, defined as further invasive measure in the respective groin [Срок оценки: Up to 30 days postoperatively]
• Lenght of hospital stay [Срок оценки: Up to 30 days postoperatively]
• 30-day mortality [Срок оценки: Up to 30 days postoperatively]

Критерии участия

Критерии включения

• adult patients undergoing vascular surgery procedures in the groin
• signed informed consent for study participation

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University Hospital Basel — Basel

Идентификаторы

NCT: NCT07499206 · GCH-008_LymphFistula-Pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗