Contact information
Type
Scientific
Primary contact
Prof Hector Ortiz
ORCID ID
Contact details
Hospital Virgen del Camino
Irunlarrea 4
Pamplona
31008
Spain
+34 65 98 67 210
hortizhu@cfnavarra.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09/01; PI08/90196
Study information
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
Study hypothesis
A decreased faecal load in the surgical wound diminished the incidence of surgical site infection.
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
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
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
Phase
Not Applicable
Drug names
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 trial start date
01/06/2009
Overall trial end date
01/06/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged above 18 years, either sex
2. Colon and rectal cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
738
Participant 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
Recruitment start date
01/06/2009
Recruitment end date
01/06/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Virgen del Camino
Pamplona
31008
Spain
Sponsor information
Organisation
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Sponsor details
C/ Sinesio Delgado 4 - 6 (entrada por Avda. Monforte de Lemos
5.)
Madrid
28029
Spain
Registro.general@isciii.es
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
Spanish National Research Council (Consejo Superior de Investigaciones Cientificas [CSIC]) (Spain)
Alternative name(s)
Spanish National Research Council, CSIC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Spain
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22430092
Publication citations
-
Results
Ortiz H, Armendariz P, Kreisler E, Garcia-Granero E, Espin-Basany E, Roig JV, Martín A, Parajo A, Valero G, Martínez M, Biondo S, Influence of rescrubbing before laparotomy closure on abdominal wound infection after colorectal cancer surgery: results of a multicenter randomized clinical trial., Arch Surg, 2012, 147, 7, 614-620, doi: 10.1001/archsurg.2012.150.