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

ISRCTN	ISRCTN55624793
DOI	https://doi.org/10.1186/ISRCTN55624793
Protocol serial number	001
Sponsor	Hospital del Mar (Spain)
Funder	Spanish Ministry of Health, Investigation of Sanitary Funding (Fondo de Investivación Sanitaria Ministerio de Sanidad y Consumo) (Spain)

Submission date: 02/07/2009
Registration date: 19/08/2009
Last edited: 27/01/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Miguel Pera
Scientific

Colorectal Surgery Unit
Department of Surgery
Hospital del Mar
Passeig Marítim 25 - 29
Barcelona
08003
Spain

Phone	+34 93 24 83 207
Email	mpera@imas.imim.es

Study information

Primary study design	Interventional
Study design	Randomised controlled two-arm trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised clinical trial of the inflammatory and angiogenic responses of open and laparoscopic surgery for colon cancer
Study acronym	ARALOS
Study objectives	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(s)	Hospital del Mar Comité Ético de Investigación Clínica (IRB) approved in June 2003 (reference number 2003/1621/I)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Patients with resectable colon cancer, either sex 2. Written informed consent 3. Aged older than 18 years
Key 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
Date of first enrolment	01/06/2004
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Spain

Study participating centre

Colorectal Surgery Unit

Barcelona
08003
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes