Title: Development of a resorbable sealing patch for the prevention of anastomotic leakage after colorectal cancer surgical treatment

Project no.: 280929

Call (part) identifier: FP7-NMP-2011-SMALL-5

Duration: May 1st, 2012 – April 30th, 2015

Consortium:

1. Universita Degli Studi Di Trieste, Trieste, Italy

2. Universiteit Maastricht, Maastricht, The Netherlands

3. Sigea SRL, Trieste, Italy

4. RESCOLL RC,  Pessac Cedex, France

5. FMC Biopolymer AS FMC, Sandvika  Norway

6. Innovation Enterprise “IMPULS” mgr inż Władysław Fediuk, Gdansk, Poland

Anastomotic Leakage (AL) is a major complication of any bowel resection, which occurs when proper and rapid regeneration of the resected bowel extremities do not take place. It has a negative impact on the health of the patient and often leads to death.
Colorectal cancer is one of the highest causes of cancer related death in Europe and it is the second most common tumor in Poland for both men and women. The number of AL cases in Europe varies between different countries. Numbers up to 21% of patients and mortality rates up to 39% of cases are reported.

The occurence of AL after surgery requires longer treatment, application of new drugs and often re-operation. These factors raise the costs of the patient therapy. The solution of the project helps to eliminate or reduce the risk of AL and would lead to significant savings for the health care.

Methods:
The patch will be made from natural-derived bioresorbable polysaccharides. The patch is intended to be used at the end of the gastrointestinal procedure and is placed around the newly formed bowel anastomosis. The patch is designed to promote tissue regeneration, and to seal the external part of the intestine, which will increase early structural integrity and reduce leakage. 

Results:
First prototypes of the biopolymeric patch have been prepared in different sizes and shapes. The test methods for characterization of the properties of the patch (in vitro, ex vivo and in vivo) have been developed and are continuously updated. Different sterilization procedures have been investigated and selected methods are found eligible for this sensitive product.

Figure 1. A) Colorectal cancer resection; B) Sutured bowel (anastomosis); C) Sealing of the anastomosis with a biomaterial patch.

The AnastomoSEAL consortium involves:
Two academic units: University of Trieste and Maastricht University;
Four industrial partners: RESCOLL, SIGEA, FMC Biopolymer, IMPULS.

The University of Trieste is the project coordinator.

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