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Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery
Sponsor: Vivostat
Summary
Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs. This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x125 patients The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique. The secondary objectives of the study are to investigate on an exploratory basis: * The frequency of anastomotic insufficiency (ISREC Criteria) severity * Staple line bleeding requiring surgical intervention * The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone. are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.
Official title: Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery - a Single-blind, Randomized, Multicenter Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2021-12-23
Completion Date
2024-12-31
Last Updated
2024-07-25
Healthy Volunteers
No
Conditions
Interventions
Obsidian ASG
Application of an autologous platelet-rich fibrin matrix
Locations (13)
Krankenhaus der Barmherzigen Brûder
Graz, Austria
Kepler Universitätsklinikum GmbH, Med campus III
Linz, Austria
Krankenhaus der Barmherzigen Brüder Wien
Vienna, Austria
Landesklinikum Wienerneustadt
Wiener Neustadt, Austria
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, Germany
Universität Augsburg
Augsburg, Germany
Diakonissenkrankenhaus Dresden
Dresden, Germany
Klinikum Fürth
Fürth, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
University Milano
Milan, Italy
University Hospital Belgrade
Belgrade, Serbia
Granada Hospital
Granada, Spain
Consorci Hospital General Universitari de Valencia
Valencia, Spain