Study for the Efficacy & Security Analysis in the Protection of Ileocolic

Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch. — ANASTOPATCH

Adenocarcinoma Colon Clinical Trial

Official title:
Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04109105
Study type	Observational
Source	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact	Juan Carlos Gómez Rosado
Phone	955 00 80 00
Email	juanc.gomez.rosado.sspa@juntadeandalucia.es
Status	Recruiting
Phase
Start date	January 15, 2019
Completion date	May 15, 2020

Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch. — ANASTOPATCH

Clinical Trial Summary

Clinical Trial Description

Study Design

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