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 | https://doi.org/10.1186/ISRCTN19463413 |
| Secondary identifying numbers | 09/01; PI08/90196 |
- Submission date
- 15/05/2009
- Registration date
- 17/06/2009
- Last edited
- 05/04/2012
- 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
Prof Hector Ortiz
Scientific
Scientific
Hospital Virgen del Camino
Irunlarrea 4
Pamplona
31008
Spain
| Phone | +34 65 98 67 210 |
|---|---|
| hortizhu@cfnavarra.es |
Study information
| Study design | Prospective double blinded randomised multicentre 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 | 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 |
| Study acronym | NewOp |
| Study objectives | A decreased faecal load in the surgical wound diminished the incidence of surgical site infection. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Colorectal cancer |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/06/2009 |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 738 |
| Key inclusion criteria | 1. Aged above 18 years, either sex 2. Colon and rectal cancer |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Virgen del Camino
Pamplona
31008
Spain
31008
Spain
Sponsor information
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Research organisation
Research organisation
C/ Sinesio Delgado 4 - 6 (entrada por Avda. Monforte de Lemos, 5.)
Madrid
28029
Spain
| Registro.general@isciii.es | |
| Website | http://www.isciii.es/htdocs/index.jsp |
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Research council
Spanish National Research Council (Consejo Superior de Investigaciones Cientificas [CSIC]) (Spain)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Spanish National Research Council, El Consejo Superior de Investigaciones Científicas (CSIC), CSIC, elcsic
- Location
- Spain
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 | 01/07/2012 | Yes | No |
