Impact of Obsidian ® ASG on Anastomotic Healing

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anastomotic Leak Rectum

Intervention / Treatment
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* Procedure: Obsidian ASG®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| laparoscopic colorectal surgery<br>Patients undergoing laparoscopic colorectal surgery with use of Obsidian ASG® during primary anastomosis. | Procedure: Obsidian ASG®<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| length of Hospital stay | days spent in Hospital after undergoing colorectal surgery | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Anastomotic leak, Obisidan