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22 May 2013
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| [ Print-friendly version ] |
| The influence of two policies of closure of the laparotomy wound in the rate of surgical site infection in colorectal cancer surgery: the New Operation trial |
| ISRCTN | ISRCTN19463413 |
| DOI | 10.1186/ISRCTN19463413 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The influence of two policies of closure of the laparotomy wound in the rate of surgical site infection in colorectal cancer surgery: the New Operation trial |
| Scientific title | A prospective double blinded randomised multicentre trial of the influence of two policies of closure of the laparotomy wound in the rate of surgical site infection in colorectal cancer surgery |
| Acronym | NewOp |
| Serial number at source | 09/01; PI08/90196 |
| Study hypothesis | A decreased faecal load in the surgical wound diminished the incidence of surgical site infection. |
| Lay summary | Not provided at time of registration |
| Ethics approval | The Medical Ethics Committee of the Virgen del Camino Academic Medical Centre, Pamplona gave approval on the 7th May 2009 (ref: 6/2008). Under Spanish law, all other centres will be included under this approval. |
| Study design | Prospective double blinded randomised multicentre trial |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Colorectal cancer |
| Participants - inclusion criteria |
1. Aged above 18 years, either sex
2. Colon and rectal cancer |
| Participants - exclusion criteria |
1. Before the enrolment: emergency surgery
2. At enrolment: 2.1. Not willing to participate 2.2. Non-resectable tumours 2.3. Multi-visceral resection planned 2.4. Recurrence of colon or rectal carcinoma 2.5. Laparoscopic abdominoperineal resection 2.6. Patients programmed to place a mesh simultaneously for an incisional hernia 3. At allocation: 3.1. Non-resectable tumours 3.2. The surgeon decides to prescribe antibiotics due to faecal contamination during operation 3.3. Any violation of the protocol 4. At follow-up: 4.1. Peri-operative mortality 4.2. Patients reoperated for any reason in the first 30 days after primary surgery 4.3. Patients with an organ/space infection draining through the wound 4.4. Patients not followed for at least 30 days after surgery |
| Anticipated start date | 01/06/2009 |
| Anticipated end date | 01/06/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 738 |
| Interventions |
Control group: at the end of the operation the nurses and surgeons will change gloves, a new set of surgical instruments will be used and the surgical drapes surrounding the laparotomy will be changed.
Study group: at the end of the operation and before closing the laparotomy; the surgical assistant will retire all the surgical drapes and the surgeon will retire the plastic coverage of the wound and the wound will be covered with a povidone-soaked gauze. Nurse and surgical teams will scrub again and the surgical instruments will be changed. Total duration of follow-up: one month after the recruitment of the last patient. |
| Primary outcome measure(s) | Incidence of surgical site infection. The criteria to define surgical site infection are described by Disease Control and Prevention National Healthcare Safety Network (Spain). For the purposes of this study superficial and deep wound infections would be considered as a unique entity condition. This will be measured 30 days after the operation. |
| Secondary outcome measure(s) |
The relationship between wound infection rate and the following variables:
1. Age 2. Sex 3. Location of the tumour (colon/rectum) 4. TNM stage 5. Obesity 6. Level of glucose 7. Long course radiotherapy Measured 30 days after the operation. |
| Sources of funding | Spanish National Research Council (Consejo Superior de Investigaciones Cientificas [CSIC]) (Spain) |
| Trial website | |
| Publications | 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22430092 |
| Contact name | Prof Hector Ortiz |
| Address |
Hospital Virgen del Camino
Irunlarrea 4 |
| City/town | Pamplona |
| Zip/Postcode | 31008 |
| Country | Spain |
| Tel | +34 65 98 67 210 |
| Fax | +34 94 82 49 942 |
| hortizhu@cfnavarra.es | |
| Sponsor | Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain) |
| Address | C/ Sinesio Delgado 4 - 6 (entrada por Avda. Monforte de Lemos, 5.) |
| City/town | Madrid |
| Zip/Postcode | 28029 |
| Country | Spain |
| Registro.general@isciii.es | |
| Sponsor website: | http://www.isciii.es/htdocs/index.jsp |
| Date applied | 15/05/2009 |
| Last edited | 05/04/2012 |
| Date ISRCTN assigned | 17/06/2009 |
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