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
- Conditions
- Colorectal cancerCancerMalignant neoplasm of rectosigmoid junction
- Registration Number
- ISRCTN19463413
- Lead Sponsor
- Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 738
1. Aged above 18 years, either sex
2. Colon and rectal cancer
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method The relationship between wound infection rate and the following variables:<br>1. Age<br>2. Sex<br>3. Location of the tumour (colon/rectum)<br>4. TNM stage<br>5. Obesity<br>6. Level of glucose<br>7. Long course radiotherapy<br><br>Measured 30 days after the operation.