Inflammatory Response in Laparoscopic and Open Colectomy

NCT ID: NCT00942461

Last Updated: 2009-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laparoscopic Surgery group

Group of patients that are operated with laparoscopic approach

Group Type ACTIVE_COMPARATOR

Laparoscopic colectomy

Intervention Type PROCEDURE

Laparoscopic colectomy. Epidural anaesthesia used

Open surgery Group

Group of patients operated with open approach

Group Type ACTIVE_COMPARATOR

Open colectomy

Intervention Type PROCEDURE

Open colectomy. Epidural anaesthesia used

Interventions

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Laparoscopic colectomy

Laparoscopic colectomy. Epidural anaesthesia used

Intervention Type PROCEDURE

Open colectomy

Open colectomy. Epidural anaesthesia used

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* colorectal cancer

Exclusion Criteria

* metastases
* stage 4 colorectal cancer
* recurrent disease
* chronic diseases
* obvious inflammatory condition
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ioannina

OTHER

Sponsor Role collaborator

G. Hatzikosta General Hospital

OTHER

Sponsor Role lead

Responsible Party

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G. Hatzikosta General Hospital, Ioannina, Greece

Locations

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G Hatzikosta General Hospital

Ioannina, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 21898023 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21567262 (View on PubMed)

Other Identifiers

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GHDS-12345-4

Identifier Type: -

Identifier Source: secondary_id

GH-1948-04

Identifier Type: -

Identifier Source: org_study_id

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