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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-02

Study Completion Date

2019-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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colectomy

colectomy resection

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Daniela Rega

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCSS Pascale

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Paolo Delrio

Role: primary

[email protected]

00390815903554

Other Identifiers

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04/17oss

Identifier Type: -

Identifier Source: org_study_id

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