Post-operative inflammatory and angiogenic response in patients with resectable colon cancer: a randomised clinical trial comparing open versus laparoscopic surgery

Completed

• Conditions: Colon cancer; Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN55624793
• Lead Sponsor: Hospital del Mar (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Patients with resectable colon cancer, either sex
2. Written informed consent
3. Aged older than 18 years

Exclusion Criteria

1. Patients with metastasic disease
2. Patients with locally advanced colon cancer
3. Patients undergoing emergency surgery
4. Transverse colon and splenic flexure cancer
5. Patients with a second neoplasm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Post-operative vascular endothelial growth factor (VEGF) serum and peritoneal fluid levels<br>2. Post-operative platelet derived growth factor (PDGF) serum and peritoneal fluid levels <br>3. Microvascular density determined in serum and peritoneal fluid on in vitro angiogenesis assay<br>4. Capillary length determined in serum and peritoneal fluid on in vitro angiogenesis assay<br><br>Samples obtained at baseline, 12, 24 and 48 hours and post-operative day 4.

Secondary Outcome Measures

Name	Time	Method
1. Levels of pro-inflammatory cytokines interleukin-6 (IL-6) and interleukin-1 beta (IL-1 beta) determined in serum and peritoneal fluid<br>2. Correlation between pro-inflammatory and angiogenic cytokines<br><br>Samples obtained at baseline, 12, 24 and 48 hours and post-operative day 4.