Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery

CompletedOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

November 8, 2023

Study Completion Date

November 8, 2023

Conditions
Anastomotic Leak RectumRectal CancerAnastomotic Leakage
Interventions
OTHER

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."

Trial Locations (1)

8200

Department of Surgery, Aarhus University Hospital, Aarhus

All Listed Sponsors
collaborator

Danish Cancer Society

OTHER

lead

University of Aarhus

OTHER

NCT05293054 - Healing of Rectal Anastomosis Sealed With a Concentrate Derived From the Patient's Blood, After Rectal Cancer Surgery | Biotech Hunter | Biotech Hunter