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ReAL Trial (Rectal Anastomotic seaL)

NCT03941938 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-10-20

No results posted yet for this study

Summary

The problem of anastomotic leak is particularly relevant in rectal surgery. Many risk factors have been recognized in the onset of this complication. Preventing the anastomotic leak can bring benefits to the patient and the health system.

Several attempts have been proposed to reduce the risk of anastomotic leakage in rectal cancer surgery including suture protection with omental flap and external suture reinforcement by biological glue or mesh.

Cyanoacrylate (Glubran 2®) is a synthetic glue with sealing, adhesive and hemostatic properties widely used in surgery. The sealing effect creates an antiseptic barrier against bacteria.

The hypothesis is that the application of nebulized cyanoacrylate to the colo-rectal anastomosis in open or laparoscopic/robotic rectal surgery can prevent the leakage

Conditions

Interventions

PROCEDURE

Cyanoacrylate reinforcement

Anastomosis Reinforcement with with nebulization of 1cc of glue on the anastomosis line

PROCEDURE

No reinforcement

Nothing applied on the anastomosis line

Sponsors & Collaborators

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Principal Investigators

  • Donato Altomare, Prof · Societa Italiana di Chirurgia ColoRettale

  • Arcangelo Picciariello, MD · Societa Italiana di Chirurgia ColoRettale

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2020-12-02
Completion
2021-07-02

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941938 on ClinicalTrials.gov