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

NCT03380858 | Unknown

• 1 other identifier: 04/17oss
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• fistula incidence

  From day of surgery up to 30 postoperative days

Secondary Outcomes (2)

• anastomitic bleeding

  From day of surgery up to 30 postoperative days

• infection

  From day of surgery up to 30 postoperative days

Interventions

colectomy DEVICE

colectomy resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

390 consecutive patients undergoing colorectal resective surgery with intestinal anastomosis

You may qualify if:

• Informed consent
• patients undergoing to oncologic colorectal surgery with colorectal anastomosis

You may not qualify if:

• refuse informed consent
• patients undergoing to oncologic colorectal surgery without colorectal anastomosis

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

IRCSS Pascale

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 21, 2017
• Study Start: November 2, 2017
• Primary Completion: December 2, 2017
• Study Completion: May 2, 2019
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

IT (1)