Condition category
Cancer
Date applied
02/07/2009
Date assigned
19/08/2009
Last edited
27/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Miguel Pera

ORCID ID

Contact details

Colorectal Surgery Unit
Department of Surgery
Hospital del Mar
Passeig Marítim 25 - 29
Barcelona
08003
Spain
+34 93 24 83 207
mpera@imas.imim.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Randomised clinical trial of the inflammatory and angiogenic responses of open and laparoscopic surgery for colon cancer

Acronym

ARALOS

Study hypothesis

The increased inflammatory response in patients with colon cancer undergoing open resection compared with laparoscopic surgery is associated with an increased angiogenic response.

Ethics approval

Hospital del Mar Comité Ético de Investigación Clínica (IRB) approved in June 2003 (reference number 2003/1621/I)

Study design

Randomised controlled two-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colon cancer

Intervention

Patients are randomised to either laparoscopic or open colectomy. Serum and peritoneal fluid samples are obtained at baseline, 12, 24 and 48 hours and post-operative day 4. Peritoneal fluid samples are obtained through an aspirative drain.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Post-operative vascular endothelial growth factor (VEGF) serum and peritoneal fluid levels
2. Post-operative platelet derived growth factor (PDGF) serum and peritoneal fluid levels
3. Microvascular density determined in serum and peritoneal fluid on in vitro angiogenesis assay
4. Capillary length determined in serum and peritoneal fluid on in vitro angiogenesis assay

Samples obtained at baseline, 12, 24 and 48 hours and post-operative day 4.

Secondary outcome measures

1. Levels of pro-inflammatory cytokines interleukin-6 (IL-6) and interleukin-1 beta (IL-1 beta) determined in serum and peritoneal fluid
2. Correlation between pro-inflammatory and angiogenic cytokines

Samples obtained at baseline, 12, 24 and 48 hours and post-operative day 4.

Overall trial start date

01/06/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/06/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Spain

Trial participating centre

Colorectal Surgery Unit
Barcelona
08003
Spain

Sponsor information

Organisation

Hospital del Mar (Spain)

Sponsor details

Passeig Maritim 25 - 29
Barcelona
08003
Spain
+34 63 97 64 484
mpera@imas.imim.es

Sponsor type

Hospital/treatment centre

Website

http://www.hospitaldelmar.cat

Funders

Funder type

Government

Funder name

Spanish Ministry of Health, Investigation of Sanitary Funding (Fondo de Investivación Sanitaria Ministerio de Sanidad y Consumo) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/20799296

Publication citations

  1. Results

    Pascual M, Alonso S, Parés D, Courtier R, Gil MJ, Grande L, Pera M, Randomized clinical trial comparing inflammatory and angiogenic response after open versus laparoscopic curative resection for colonic cancer., Br J Surg, 2011, 98, 1, 50-59, doi: 10.1002/bjs.7258.

Additional files

Editorial Notes