Impact of Obsidian ® ASG on Anastomotic Healing

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

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%.

Study Overview

• Status: Completed
• Conditions: Anastomotic Leak Rectum
• Intervention / Treatment: Procedure: Obsidian ASG®

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.

• Study Type: Observational
• Enrollment (Actual): 270

Contacts and Locations

• Study Contact: Name: Andreas Shamiyeh, Prof.Dr; Phone Number: +4357680832133; Email: andreas.shamiyeh@kepleruniklinikum.at
• Study Contact Backup: Name: Bettina Klugsberger, Dr; Phone Number: +43576808373031; Email: bettina.klugsberger@kepleruniklinikum.at

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Clinic for General and Visceral Surgery, Kepler University Clinic Linz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who undergoing elective laparoscopic colorectal surgery with a primary left-sided anastomosis treatment

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic colorectal surgery; Patients undergoing laparoscopic colorectal surgery with use of Obsidian ASG® during primary anastomosis.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic leak rate	Anastomotic leak rate after colorectal surgery with Primary anastomosis	20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of Hospital stay	days spent in Hospital after undergoing colorectal surgery	20 days
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	20 days

Collaborators and Investigators

• Sponsor: Kepler University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal surgery; Anastomotic leak; Obisidan
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: Obsidian-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No