Colorectal cancer Cancer Malignant neoplasm of rectosigmoid junction
Conditions
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
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
Sponsors
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged above 18 years, either sex 2. Colon and rectal cancer
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Outcome results
None listed