Double Blinded Randomized Clinical Trial of the Effect of Open Versus Laparoscopic Colectomy on Neutrophils in Patients With Colon Cancer

Summary

The purpose of this study is:

* to determine neutrophil activity in patients with colon cancer,
* to determine levels sFas, sFasL and IL - 17 in serum of healthy volunteers and colon cancer patients and establish its prognostic value,
* to elucidate the relationship between serum sFas, sFasL and IL - 17 levels and clinicopathologic features of colon cancer,
* to compare the influence of laparoscopic and conventional procedures on postoperative serum sFas and sFasL levels in colon cancer patients
* to compare the influence of laparoscopic and conventional procedures on postoperative serum IL - 17 levels in colon cancer patients
* to compare the influence of laparoscopic and conventional procedures on postoperative neutrophil functions
* to confirm the expression of FasL protein in human colorectal cancer and elucidate the relationship between FasL expression and clinicopathologic features of the disease, to establish the prevalence of Fas in primary colon adenocarcinomas and elucidate the relationship between FasL expression and clinicopathologic features of the disease
* to determine the functional activity of tumour infiltrating neutrophils

Conditions

• Colonic Neoplasms

Interventions

PROCEDURE

Therapeutic conventional colorectal surgery

Patients with colorectal cancer undergo open laparotomy and colorectal resection

PROCEDURE

Therapeutic laparoscopic colorectal surgery

Patients with colorectal cancer undergo laparoscopic colorectal resection

OTHER

Peripheral blood sampling and performing: ELISA test of sFas, sFasL, IL - 17 and Bursttest

Informed consent will be obtained.Blood samples will be obtained at one time point. .Samples will be processed to serum, using a refrigerated centrifuge, then stored at -80C until analysis. Peripheral blood samples for measurement of oxidative burst in neutrophils will be collected into heparinised blood tube.Serum concentrations of sFas will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fas MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA). Serum concentrations of sFasL will be quantitative determinated by a sandwich enzyme immunoassay technique (ELISA) using specific anti-Fasl MoAbs, Human sFas Immunoassay (Code: DFS00; QUANTIKINE R\&D Systems Inc, Minneapolis, USA).Respiratory burst neutrophil production will be determined quantitatively by flow cytometry using a commercial kit Bursttest Kit (Cat. No: 10-0200; ORPEGEN Pharma, Germany)

Sponsors & Collaborators

• Ministry of Science, Education and Sport, Republic of Croatia

  collaborator OTHER_GOV

• University Hospital Dubrava

  lead OTHER

Principal Investigators

• Igor Stipančić, MD, PhD, Profssor · University Hospital Dubrava

• Valentina Ratkajec, MD · University Hospital Dubrava

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2009-07-31

Completion

2010-06-30

Countries

• Croatia

Study Locations