Impact of Obsidian ® ASG on Anastomotic Healing

Kepler University Hospital

Status: Completed

Conditions: Anastomotic Leak Rectum

Treatments: Procedure: Obsidian ASG®

Study type: Observational

Funder types: Other

Identifiers

NCT04386148

Obsidian-20

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

270 participants in 1 patient group

laparoscopic colorectal surgery

Description:

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

Treatment:

Procedure: Obsidian ASG®