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The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.
Introduction:
The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.
Methods:
This is a prospective, multi-centre descriptive study commencing in June 2018. As part of the elective laparoscopic colorectal surgery, an autologous fibrin matrix was used as part of anastomotic technique in conjunction with activated thrombocytes (Obsidian ASG®). During anastomosis, this matrix was applied after resection onto the colorectal tissue surfaces with the aim of triggering tissue regeneration and improved wound healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic colorectal surgery | Patients undergoing laparoscopic colorectal surgery with use of Obsidian ASG® during primary anastomosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obsidian ASG® | Procedure | As part of the elective laparoscopic colorectal surgery, an autologous fibrin matrix was used as part of anastomotic technique in conjunction with activated thrombocytes (Obsidian ASG®). During anastomosis, this matrix was applied after resection onto the colorectal tissue surfaces with the aim of triggering tissue regeneration and improved wound healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak rate | Anastomotic leak rate after colorectal surgery with Primary anastomosis | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| feacal blood | number of Patients with feacal blood after colorectal surgery with Primary anastomosis | 20 days |
| fever | number of patients with fever higher than 38°C after colorectal surgery |
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Inclusion Criteria:
elective laparoscopic colorectal surgery with a primary anastomosis treatment
Exclusion Criteria:
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patients who undergoing elective laparoscopic colorectal surgery with a primary left-sided anastomosis treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for General and Visceral Surgery, Kepler University Clinic Linz | Linz | Upper Austria | 4020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21600561 | Background | Fraccalvieri D, Biondo S, Saez J, Millan M, Kreisler E, Golda T, Frago R, Miguel B. Management of colorectal anastomotic leakage: differences between salvage and anastomotic takedown. Am J Surg. 2012 Nov;204(5):671-6. doi: 10.1016/j.amjsurg.2010.04.022. Epub 2011 May 19. | |
| 20004450 | Background | Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11. |
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| ID | Term |
|---|---|
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 20 days |
| length of Hospital stay | days spent in Hospital after undergoing colorectal surgery | 20 days |
| 18034250 | Background | Buchs NC, Gervaz P, Secic M, Bucher P, Mugnier-Konrad B, Morel P. Incidence, consequences, and risk factors for anastomotic dehiscence after colorectal surgery: a prospective monocentric study. Int J Colorectal Dis. 2008 Mar;23(3):265-70. doi: 10.1007/s00384-007-0399-3. Epub 2007 Nov 22. |