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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Application of an autologous platelet-rich fibrin matrix
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
...and 3 more locations
Anastomosis insufficiency [yes/no]
Anastomosis insufficiency after colorectal surgery with primary anastomosis
Time frame: 45 days
Anastomotic insufficiency [0/A/B/C]*
\*ISREC, International Study Group of Rectal Cancer - severity grading of anastomotic leakage
Time frame: 45 days
Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no]
Staple suture line bleeding requiring surgical intervention
Time frame: 45 days
Postoperative hospital length of stay [days]
Days spent in hospital after undergoing colorectal surgery
Time frame: 45 days
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