Status:
UNKNOWN
Double Blinded Randomized Clinical Trial of the Effect of Open Versus Laparoscopic Colectomy on Neutrophils in Patients With Colon Cancer
Lead Sponsor:
University Hospital Dubrava
Collaborating Sponsors:
Ministry of Science, Education and Sport, Republic of Croatia
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief 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 ...
Detailed Description
Colorectal cancer is the leading cause of death worldwide. Tumour cell extravasation plays a key role in tumour metastasis. There are evidences tumour cell-leukocyte interactions may support tumour ce...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All patients will be informed that additional blood and tissue samples will be taken during perioperative period for colon cancer research, and written consent will be obtained. Informed consent will be also obtained from each healthy volunteer.
- Patients with the clinical diagnosis of colorectal cancer based on colonoscopy following histological confirmation will recruited. They should be suitable for elective surgical resection of the tumour along with lymph node dissection by right and left hemicolectomy, sigmoid colectomy, and anterior resection. Clinicopathologic characteristics of these patients will be investigated based on TNM classification of malignant tumours and modified Dukes classification Inclusion criteria; age between 18 and 80 years; colorectal cancer with single tumour locating at cecum, ascending colon, descending colon, sigmoid colon or recto sigmoid junction (distance from anal verge more than 15 cm); ASA I-III; and informed consent.
- Exclusion criteria; patient refusal to participate in the prospective data collection; prior midline laparotomy; emergency surgery or urgent operation within 24 h after admission to the hospital; conversion to laparotomy; mechanic ileus; perforation or abscess with septic inflammatory response syndrome; planned stoma, low anterior resection or rectal extirpation; known immunological dysfunction (human immunodeficiency virus infection); presence of ongoing infection or infective chronic diseases; severe cardiovascular disease (New York Heart Association class higher than 3) or pulmonary insufficiency (severe pulmonary emphysema, interstitial pneumonitis, arterial PO2\<79 mmHg); advanced liver disease (Child-Pugh class C); synchronous or metachronous (within five years) malignancy; pregnant or lactating women; continuous systemic steroid therapy; drug addiction; previous chemotherapy, radiotherapy or immune therapy.
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00860691
Start Date
January 1 2008
End Date
June 1 2010
Last Update
March 26 2010
Active Locations (1)
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1
University Hospital "Dubrava"
Zagreb, Croatia, 10 000