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| Name | Class |
|---|---|
| Raffeiner GmbH | INDUSTRY |
| European Commission | OTHER |
| AF Schimetta GMbH | UNKNOWN |
| Rivolution GmbH |
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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:
are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Obsidian ASG | Active Comparator | Anastomosis treatment using standard procedure and Obsidian ASG |
|
| Without Obsidian ASG | No Intervention | Anastomosis treatment using standard procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obsidian ASG | Device | Application of an autologous platelet-rich fibrin matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis insufficiency [yes/no] | Anastomosis insufficiency after colorectal surgery with primary anastomosis | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic insufficiency [0/A/B/C]* | *ISREC, International Study Group of Rectal Cancer - severity grading of anastomotic leakage | 45 days |
| Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no] |
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Inclusion Criteria:
The following inclusion criteria will be considered:
Exclusion Criteria:
The following exclusion criteria will be considered:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Shamiyeh, Prim.Doz.Dr. | Kepler Universitätsklinikum Gmbh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Barmherzigen Brûder | Graz | 8020 | Austria | |||
| Kepler Universitätsklinikum GmbH, Med campus III |
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| UNKNOWN |
Multicenter, prospective, randomized, single-blind
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Staple suture line bleeding requiring surgical intervention |
| 45 days |
| Postoperative hospital length of stay [days] | Days spent in hospital after undergoing colorectal surgery | 45 days |
| Linz |
| 4021 |
| Austria |
| Krankenhaus der Barmherzigen Brüder Wien | Vienna | 4041 | Austria |
| Landesklinikum Wienerneustadt | Wiener Neustadt | 2700 | Austria |
| RoMed Klinikum Rosenheim | Rosenheim | Bavaria | 83022 | Germany |
| Universität Augsburg | Augsburg | 86152 | Germany |
| Diakonissenkrankenhaus Dresden | Dresden | 01099 | Germany |
| Klinikum Fürth | Fürth | 90766 | Germany |
| Klinikum Nürnberg Nord | Nuremberg | 90419 | Germany |
| University Milano | Milan | 20122 | Italy |
| University Hospital Belgrade | Belgrade | 11000 | Serbia |
| Granada Hospital | Granada | 18016 | Spain |
| Consorci Hospital General Universitari de Valencia | Valencia | 46016 | Spain |