Impact of Obsidian ® ASG on Anastomotic Healing

Anastomotic Leak Rectum Clinical Trial

Official title:

Impact of Obsidian® ASG Autologous Platelet-rich Fibrin Matrix on Anastomotic Healing in Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386148
• Other study ID #: Obsidian-20
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2023
• Source: Kepler University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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%.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

elective laparoscopic colorectal surgery with a primary anastomosis treatment

Exclusion Criteria:

1. pregnancy

2. Breastfeeding period

3. concomitant disease with the potential for a relevant impairment of the anastomosis durability (leukemia, cirrhosis of the liver, Child Pugh A-C)

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Rectum

Intervention

Procedure:
• Obsidian ASG®
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.

Locations

Country	Name	City	State
Austria	Clinic for General and Visceral Surgery, Kepler University Clinic Linz	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Kepler University Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leak rate	Anastomotic leak rate after colorectal surgery with Primary anastomosis	20 days
Secondary	feacal blood	number of Patients with feacal blood after colorectal surgery with Primary anastomosis	20 days
Secondary	fever	number of patients with fever higher than 38°C after colorectal surgery	20 days
Secondary	length of Hospital stay	days spent in Hospital after undergoing colorectal surgery	20 days