Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.isciii.es/htdocs/index.jsp

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

Federal/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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22430092

Publication citations

  1. 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.

Editorial Notes