REINFORCEMENT ANASTOMOSIS IN ONCOLOGIC COLORECTAL SURGERY
Overview
- Phase
- Not Applicable
- Sponsor
- National Cancer Institute, Naples
- Enrollment
- 390
- Locations
- 1
- Primary Endpoint
- fistula incidence
Overview
Brief Summary
In colorectal surgery about 30% of postoperative mortality is attributed to anastomotic leak, whit an incidence range between 1.8% and 15.9%. Preventing the anastomotic leak can therefore bring benefits to the patient and the health system. To date we have technologically advanced suturizers and the correct realization (well-vascularized margins, not in tension, etc.) remains crucial to prevent anastomotic dehiscence. Experimental results demonstrate that modified cyanacrylate is a suitable potential "reinforcement" on intestinal anastomoses (manual or linear intra-corporeal). Applied after mechanical anastomosis, it polymerizes in a short time, closing the spaces of the suture line between one point and the other, expressing an adhesive, hemostatic and sealing action on the tissues, also creating an effective antiseptic barrier towards of the most common infectious or pathogenic agents.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Informed consent
- •patients undergoing to oncologic colorectal surgery with colorectal anastomosis
Exclusion Criteria
- •refuse informed consent
- •patients undergoing to oncologic colorectal surgery without colorectal anastomosis
Outcomes
Primary Outcomes
fistula incidence
Time Frame: From day of surgery up to 30 postoperative days
Secondary Outcomes
- infection(From day of surgery up to 30 postoperative days)
- anastomitic bleeding(From day of surgery up to 30 postoperative days)
Investigators
Daniela Rega
doctor
National Cancer Institute, Naples