Clinical trial NCT04386148: Impact of Obsidian ® ASG on Anastomotic Healing
Official title: Impact of Obsidian® ASG Autologous Platelet-rich Fibrin Matrix on Anastomotic Healing in Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak Rectum
Keywords: Colorectal surgery
Anastomotic leak
Obisidan
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergoing elective laparoscopic colorectal surgery with a primary left-sided anastomosis treatment

Brief 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%.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anastomotic leak rate
timeFrame: 20 days
Secondary outcomes:
measure: feacal blood
timeFrame: 20 days
measure: fever
timeFrame: 20 days
measure: length of Hospital stay
timeFrame: 20 days
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Clinic for General and Visceral Surgery, Kepler University Clinic Linz
state: Upper Austria
Study officials:
References:
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.
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.
citation: 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.