50
Participants
Start Date
December 15, 2021
Primary Completion Date
November 8, 2023
Study Completion Date
November 8, 2023
Application of autologous fibrin matrix (Obsidian)
"When the patient is anaesthetized, 120 ml venous blood is collected for preparation of the autologous fibrin matrix. The blood is processed in the Vivostat® unit for 30 minutes making a 5-6 ml concentrate ready for application by use of a specific endoscopic kit device.~When the rectal cancer resection is completed and the specimen is extracted, the Obsidian will be applied using minimal invasive technique and the endoscopic kit device.~Step 1: 1.5-2ml. Obsidian is applied onto the rectal stump, with the circular stapler device inserted into the rectal stump. The circular stapler is then closed, but not yet fired.~Step 2: 2.5-3ml Obsidian is applied 360 degrees around the anastomosis, while taking care not to increase tension on the anal intestine end. The circular stapler is then fired and removed. The water-air-leak test is performed according to standard clinical practice. Step 3: The remaining part of the Obsidian is then sealed 360 degrees around the anastomosis."
Department of Surgery, Aarhus University Hospital, Aarhus
Danish Cancer Society
OTHER
University of Aarhus
OTHER