Impact of Obsidian ASG on Anastomotic Healing

  • STATUS
    Recruiting
  • participants needed
    101
  • sponsor
    Kepler University Hospital
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Updated on 5 August 2020
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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.

Details
Condition Anastomotic Leak Rectum
Age 18years - 100years
Treatment Obsidian ASG®
Clinical Study IdentifierNCT04386148
SponsorKepler University Hospital
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

elective laparoscopic colorectal surgery with a primary anastomosis treatment

Exclusion Criteria

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