ISRCTN19463413CompletedNot Applicable
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
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)0 sites738 target enrollmentStarted: June 17, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 738
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Aged above 18 years, either sex
- •2. Colon and rectal cancer
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
Investigators
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