NCT00942461

Brief Summary

This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

8 months

First QC Date

July 20, 2009

Last Update Submit

July 20, 2009

Conditions

Colorectal Cancer

Keywords

a-defensinsTLRsInflammatory CytokinesCRPNo metastasesNo other obvious inflammationNo chronic diseases

Outcome Measures

Primary Outcomes (1)

  • Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer

    preoperative, intraoperative, 6h postop, 24h postop

Study Arms (2)

Laparoscopic Surgery group

ACTIVE COMPARATOR

Group of patients that are operated with laparoscopic approach

Procedure: Laparoscopic colectomy

Open surgery Group

ACTIVE COMPARATOR

Group of patients operated with open approach

Procedure: Open colectomy

Interventions

Laparoscopic colectomyPROCEDURE

Laparoscopic colectomy. Epidural anaesthesia used

Laparoscopic Surgery group
Open colectomyPROCEDURE

Open colectomy. Epidural anaesthesia used

Open surgery Group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • colorectal cancer

You may not qualify if:

  • metastases
  • stage 4 colorectal cancer
  • recurrent disease
  • chronic diseases
  • obvious inflammatory condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G Hatzikosta General Hospital

Ioannina, 45001, Greece

Location

Related Publications (2)

  • Tsimogiannis KE, Tellis CC, Tselepis AD, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Toll-like receptors in the inflammatory response during open and laparoscopic colectomy for colorectal cancer. Surg Endosc. 2012 Feb;26(2):330-6. doi: 10.1007/s00464-011-1871-2. Epub 2011 Sep 5.

    PMID: 21898023DERIVED

  • Tsimogiannis KE, Telis K, Tselepis A, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Alpha-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer. World J Surg. 2011 Aug;35(8):1911-7. doi: 10.1007/s00268-011-1140-5.

    PMID: 21567262DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

GR(1)