| Objective: |
The objective of this study is to identify if addition of selective selective decontamination of the digestive tract (SDD) using oral antibiotics (OAB) pre-operatively to standard surgical antibiotic prophylaxis improves surgical site infection (SSI) rates following elective colorectal resectional surgery. |
| Aim: |
The aim of the study is to determine whether a combination of preoperative SDD and single dose perioperative intravenous antibiotics reduces the incidence of postoperative complications compared to single dose perioperative intravenous antibiotics alone. The primary endpoint is the incidence of SSIs. Secondary endpoints are infectious complications other than SSIs, length of hospital stay, postoperative complications as per Clavien Dindo Classification, anastomotic leakage where applicable and mortality. |
| Methods: |
This is a multicentre, non-blinded, randomised controlled trial. Adult patients (aged ≥ 18 years) scheduled for elective laparoscopic, open and robotic assisted colon or rectal surgery for benign or malignant disease are eligible for inclusion. Exclusion criteria includes: (1) inability to provide informed consent (2) acute surgery for bleeding, perforation or obstruction, (3) pregnancy or lactating, (4) uncontrolled diabetes mellitus, (5) preoperative steroid use, (6) antibiotic use within 2 weeks of proposed elective surgery date and (7) previous allergic reaction to the antibiotics utilised in this study. The trial protocol will be submitted to the Ethics Board of each participating insitution. Patients are randomized to preoperative SDD and single dose perioperative intravenous antibiotics (intervention group) or to single dose perioperative intravenous antibiotics alone (control group) using a computer generated random code. The patients in the intervention group receive the SDD preparation consisting of Neomycin 1g and Erythromycin 1g to be taken the day before surgery. All patients in both groups receive the same intravenous antibiotic prophylaxis consisting of 1.2g Augmentin within 30 minutes of commencing surgery. Patients sensitive or allergic to penicillin receive alternative antibiotics upon induction of anaesthesia. These include Ciprofloxacin 400mg IV and Metronidazole 500mg IV. Neither group receives any further antibiotics postoperatively. Patients in whom the operation is of such a length as to require a second dose of intravenous antibiotics will be noted. Patients in whom there is intraoperative contamination requiring additional perioperative antibiotics and ongoing postoperative antibiotics will be excluded from the analysis. All patients recruited in this study will follow the principles of the ERAS protocol. SSIs will be classified as either incisional or deep organ space. Incisional SSI is classified as surperfical or deep incisional SSI. Deep incisional SSI involves infection of the deep fascial and muscular layers beneath overlying skin and subcutaneous tissue involved in superficial SSI. Deep space SSI is described as any part of anatomy involved other than the incised body wall layers that were opened or manipulated during surgery. The different types of SSIs are diagnosed based on the surgical site infection criteria as per the Centers for Disease Control and Prevention (CDC). 30-day follow-up will be performed. |
| Reason for International Trial: |
1. To shorten recruitment interval which will enhance the ability to report study findings with the potential to impact on patient care
2. Improves relevance of study findings to international patient cohorts
3. Dissemination of study findings to international audience
4. Build collaborative networks for colorectal surgery research |