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

REINFORCEMENT ANASTOMOSIS IN ONCOLOGIC COLORECTAL SURGERY

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03380858
Acronym
ANASTOSEAL
Enrollment
390
Registered
2017-12-21
Start date
2017-11-02
Completion date
2019-05-02
Last updated
2018-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DEVICEcolectomy

colectomy resection

Sponsors

National Cancer Institute, Naples
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
fistula incidenceFrom day of surgery up to 30 postoperative days

Secondary

MeasureTime frame
anastomitic bleedingFrom day of surgery up to 30 postoperative days
infectionFrom day of surgery up to 30 postoperative days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026