REINFORCEMENT ANASTOMOSIS WITH Modified Cyanacrylate IN Patients Undergoing to Oncologic Colorectal Surgery With Colorectal Anastomosis
- Conditions
- Colorectal Cancer
- Registration Number
- NCT03380858
- Lead Sponsor
- National Cancer Institute, Naples
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 390
- Informed consent
- patients undergoing to oncologic colorectal surgery with colorectal anastomosis
- refuse informed consent
- patients undergoing to oncologic colorectal surgery without colorectal anastomosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fistula incidence From day of surgery up to 30 postoperative days
- Secondary Outcome Measures
Name Time Method infection From day of surgery up to 30 postoperative days anastomitic bleeding From day of surgery up to 30 postoperative days
Trial Locations
- Locations (1)
IRCSS Pascale
🇮🇹Napoli, Italy