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 |
| Secondary identifying numbers | 001 |
- 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
Scientific
Colorectal Surgery Unit
Department of Surgery
Hospital del Mar
Passeig Marítim 25 - 29
Barcelona
08003
Spain
| Phone | +34 93 24 83 207 |
|---|---|
| mpera@imas.imim.es |
Study information
| Study design | Randomised controlled two-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/06/2004 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
08003
Spain
Sponsor information
Hospital del Mar (Spain)
Hospital/treatment centre
Hospital/treatment centre
Passeig Maritim 25 - 29
Barcelona
08003
Spain
| Phone | +34 63 97 64 484 |
|---|---|
| mpera@imas.imim.es | |
| Website | http://www.hospitaldelmar.cat |
"ROR" |
https://ror.org/03a8gac78 |
Funders
Funder type
Government
Spanish Ministry of Health, Investigation of Sanitary Funding (Fondo de Investivación Sanitaria Ministerio de Sanidad y Consumo) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
