Anastomotic Leak Rectum
Conditions
Keywords
Colorectal surgery, Anastomotic leak, Obisidan
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.
Interventions
PROCEDUREObsidian ASG®
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.
Sponsors
Kepler University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak rate | 20 days | Anastomotic leak rate after colorectal surgery with Primary anastomosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria
Outcome results
None listed