Extrait

To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to stapled anastomosis after lower anterior resection (LAR). This will be done by assessing the absence of clinical anastomotic leak (success) within 40 days post operatively. Clinical anastomotic leak is defined as signs and symptoms that are confirmed by one or more of the following methods: • Confirmation on imaging; • Visual confirmation (eg., reoperation/drain output).

Critère d'inclusion

• Gastrointestinal Anastomosis Leak

Liens

• euctr
• euctr
• ictrp
• ictrp