The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.
The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups. Short-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required. The intent-to-treat principle is used for the data analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
586
Mechanical bowel preparation and oral antibiotics
Omission of any bowel preparation
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia
RECRUITINGAnastomotic leak rate
Rate of anastomotic leak in patients after colon resections
Time frame: 30 days
Surgical site infection (SSI) rate
Rate of Surgical site infection
Time frame: 30 days
Intraabdominal and or pelvic abscess rate
Rate of intraabdominal and or pelvic abscess
Time frame: 30 days
Overall morbidity
Rate of patients with any complications after surgery
Time frame: 30 days
Rate of intraoperative complications
Rate of patients with intraoperative complications
Time frame: Duration of surgical procedure
Surgery duration in minutes
Time of surgical procedure
Time frame: Duration of surgical procedure
Quality of bowel preparation assessed by surgeon
Assessment of bowel preparation quality by surgeon (qualitative scale)
Time frame: Day of surgical procedure
Bowel preparation compliance
Rate of patients in experimental arm undergoing complete bowel preparation according to protocol
Time frame: Day of surgical procedure
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