REINFORCEMENT ANASTOMOSIS WITH Modified Cyanacrylate IN Patients Undergoing to Oncologic Colorectal Surgery With Colorectal Anastomosis (ANASTOSEAL)

REINFORCEMENT ANASTOMOSIS IN ONCOLOGIC COLORECTAL SURGERY

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 Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: colectomy

• Study Type: Observational
• Enrollment (Anticipated): 390

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • Recruiting
    • IRCSS Pascale
    • Contact: Paolo Delrio; Phone Number: 00390815903554; Email: p.delrio@istitutotumori.na.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

390 consecutive patients undergoing colorectal resective surgery with intestinal anastomosis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fistula incidence	From day of surgery up to 30 postoperative days

Secondary Outcome Measures

Outcome Measure	Time Frame
anastomitic bleeding	From day of surgery up to 30 postoperative days
infection	From day of surgery up to 30 postoperative days

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): December 2, 2017
• Study Completion (Anticipated): May 2, 2019

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 04/17oss

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No