Impact of Obsidian ® ASG on Anastomotic Healing

Completed

• Conditions: Anastomotic Leak Rectum
• Interventions: Procedure: Obsidian ASG®

• Registration Number: NCT04386148
• Lead Sponsor: Kepler University Hospital

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.

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Primary Completion: 2021-03-31
• Study Completion: 2021-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
laparoscopic colorectal surgery	Obsidian ASG®	Patients undergoing laparoscopic colorectal surgery with use of Obsidian ASG® during primary anastomosis.

Primary Outcome Measures

Name	Time	Method
Anastomotic leak rate	20 days	Anastomotic leak rate after colorectal surgery with Primary anastomosis

Secondary Outcome Measures

Name	Time	Method
feacal blood	20 days	number of Patients with feacal blood after colorectal surgery with Primary anastomosis
fever	20 days	number of patients with fever higher than 38°C after colorectal surgery
length of Hospital stay	20 days	days spent in Hospital after undergoing colorectal surgery

Trial Locations

Locations (1)

Clinic for General and Visceral Surgery, Kepler University Clinic Linz; 🇦🇹 Linz, Upper Austria, Austria