Impact of Obsidian ® ASG on Anastomotic Healing

Kepler University Hospital270 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

270

Conditions

Anastomotic Leak Rectum

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Clinic for General and Visceral Surgery, Kepler University Clinic Linz

Linz, Upper Austria, Austria

Outcomes

Primary Outcomes

Anastomotic leak rate

Anastomotic leak rate after colorectal surgery with Primary anastomosis

Time frame: 20 days

Secondary Outcomes

feacal blood

number of Patients with feacal blood after colorectal surgery with Primary anastomosis

Time frame: 20 days

fever

number of patients with fever higher than 38°C after colorectal surgery

Time frame: 20 days

length of Hospital stay

days spent in Hospital after undergoing colorectal surgery

Time frame: 20 days

Data from ClinicalTrials.gov

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