NCT00928928

Brief Summary

Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer

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

January 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

Enrollment Period

1.4 years

First QC Date

June 25, 2009

Last Update Submit

June 25, 2009

Conditions

Colorectal Cancer

Keywords

Lipid peroxidationProtein peroxidationDNA peroxidationRNA peroxidationCytokineshsCRPOxidative stress markersOpen surgeryLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach

    preoperative, intraoperative, 6h postop, 24h postop

Study Arms (2)

Open group

ACTIVE COMPARATOR

Group of patients operated with open approach for colorectal cancer

Procedure: Open colectomy

laparoscopic group

ACTIVE COMPARATOR

Group of patients operated with laparoscopic approach for colorectal cancer

Procedure: laparoscopic colectomy

Interventions

Open colectomyPROCEDURE

Open colectomy. Epidural anaesthesia used

Open group
laparoscopic colectomyPROCEDURE

Laparoscopic colectomy. Epidural anaesthesia used

laparoscopic group

Eligibility Criteria

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

You may qualify if:

  • colorectal cancer

You may not qualify if:

  • metastases
  • recurrent disease
  • chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G Hatzikosta General Hospital

Ioannina, 45001, Greece

Location

Related Publications (1)

  • Pappas-Gogos G, Tellis C, Lasithiotakis K, Tselepis AD, Tsimogiannis K, Tsimoyiannis E, Chalkiadakis G, Chrysos E. Oxidative stress markers in laparoscopic versus open colectomy for cancer: a double-blind randomized study. Surg Endosc. 2013 Jul;27(7):2357-65. doi: 10.1007/s00464-013-2788-8. Epub 2013 Feb 13.

    PMID: 23404145DERIVED

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

June 25, 2009

First Posted

June 26, 2009

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Last Updated

June 26, 2009

Record last verified: 2009-06

Locations

GR(1)