The REaCT NSQIP will compare oral antibiotics vs. no antibiotics, which are two standards of care treatments for preoperative preparation of the bowel prior to colorectal surgery
The divergence of clinical practice guidelines, in addition to observation from the large North American retrospective studies, suggest that surgeons and centers have not established a standard of care for the preoperative preparation of the bowel prior to colorectal surgery. Specifically, some centers are employing no preparation, others are administering a mechanical bowel preparation (MBP) and oral antibiotics and still others are using oral antibiotics alone. Recently, the Canadian Society of Colorectal Surgeons was unable to come to a consensus when attempting to update their preoperative guidelines because of the lack of agreement on best practice (personal communication). This is an important yet controversial topic in colorectal surgery and a clinical trial comparing two standard of care therapies will impact current practice in Canada. The REaCT-NSQIP study compares post-operative surgical infectious complications, length of stay, incidence of C. difficile rates, patient quality of life and cost-effectiveness in patients undergoing elective colorectal surgery with either no preparation or oral antibiotics. Data will be collected from the National Surgical Quality Improvement Program (NSQIP) and from patient quality of life questionnaires preoperatively and 30 days postoperatively In this study, it is hypothesized that it is the oral antibiotics, and not the MBP, that is responsible for the reduction in postoperative infectious surgical complications (deep or superficial surgical site infection (SSI)) in patients undergoing elective colorectal resections. This improvement in postoperative infectious complications is not anticipated to result in a clinically significant increase in postoperative C. difficile infections or antibiotic resistant hospital-acquired infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
630
No preparation before surgery
Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery
The Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Hôpital Montfort
Ottawa, Ontario, Canada
Queensway Carleton Hospital
Ottawa, Ontario, Canada
Post-Operative Surgical Infection Complication
To evaluate that use of oral antibiotics (neomycin and flagyl), administered the day prior to elective colonic resection is associated with a significant reduction in postoperative (within 30 days) surgical infectious complications (superficial and deep space infections).
Time frame: 30 days
Grade III-IV Postoperative Surgical Site Infectious Complication
To evaluate the effects of oral antibiotics on Grade III-IV (Clavien-Dindo classification) postoperative surgical site infectious complication (at 30 days).
Time frame: 30 days
Postoperative Infections Complications
To evaluate the effects of oral antibiotics on postoperative infections complications classified as deep SSI, superficial SSI or non-SSI infectious complications (i.e. urinary tract infection, pneumonia, at 30 days).
Time frame: 30 days
Overall Postoperative Complication Rate
To evaluate the effects of oral antibiotics on overall postoperative complication rate (at 30 days).
Time frame: 30 days
Postoperative Length of Stay
To evaluate the effects of oral antibiotics on postoperative length of stay (LOS).
Time frame: Number of days spent in hospital post-operatively, average of 6 days
Incidence of Postoperative C. difficile Infections
To evaluate the effects of oral antibiotics on the incidence of postoperative C. difficile infections (at 90 days).
Time frame: 90 days
Incidence of Antibiotics Resistant Postoperative Infectious Complications
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Renfrew Victoria Hospital
Renfrew, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
To evaluate the effects of oral antibiotics on the incidence of of antibiotics resistant postoperative infectious complications (at 30 days)
Time frame: 30 days
Patient Quality of Life
To evaluate the effects of oral antibiotics on patient quality of life by administering the SF-36 questionnaire, undertaken preoperatively and at 30 days postoperatively. The Short Form-36 (SF-36) is a 36-item, patient reported survey that is a measure of health status and commonly used in health economics. This SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A low score denounces a worse outcome compared to a higher score that denounces a better outcome. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
Time frame: 30 days
Direct Estimation of Health Utility Values
To evaluate the effects of oral antibiotics on patient quality of life by administering the EQ-5D-5L questionnaire, undertaken preoperatively and 30 days postoperatively. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire consists of two sections; the EQ-5D-5L descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). There are 5 levels associated with it; no problems, slight problems, moderate problems, severe problems and extreme problems. The scale range of 1-5 is used for the 5 dimensions in the descriptive system where 1 is the best outcome and 5 is the worst outcome. The Visual Analogue scale records the respondent's self-rated health on a vertical, visual scale with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom. This ranges 0 being the worst outcome to 100 being the best outcome.
Time frame: 30 days
Incremental Cost-Effectiveness Ratio
To evaluate the effects of antibiotics on the incremental cost-effectiveness ratio
Time frame: Through to study completion, an average of 2 years