Elective Colon Surgery Clinical Trial
— REaCT-NSQIPOfficial title:
A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)
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
| Status | Recruiting |
| Enrollment | 432 |
| Est. completion date | December 2026 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients undergoing elective, non-emergency colon, resection surgery or abdominal perineal resection and no other requirements exists for a mechanical bowel preparation (as determined by the operating surgeon) - 18 years of age or older - Able to provide oral consent Exclusion Criteria: - Contraindication to the oral antibiotics, including allergies or adverse reactions to either metronidazole or neomycin - Undergoing a rectal resection with a planned anastomosis (these patients will all receive MBP) - Emergency surgery where no opportunity to administer preoperative oral antibiotics exists - Requirement for a MBP (i.e. rectal resection with pelvic anastomosis, intraoperative colonoscopy, or at the discretion of the treating surgeon |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
| Canada | Queensway Carleton Hospital | Ottawa | Ontario |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | Renfrew Victoria Hospital | Renfrew | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Ottawa Hospital Research Institute |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 30 days | |
| Secondary | 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). | 30 days | |
| Secondary | 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). | 30 days | |
| Secondary | Overall Postoperative Complication Rate | To evaluate the effects of oral antibiotics on overall postoperative complication rate (at 30 days). | 30 days | |
| Secondary | Postoperative Length of Stay | To evaluate the effects of oral antibiotics on postoperative length of stay (LOS). | Number of days spent in hospital post-operatively, average of 6 days | |
| Secondary | Incidence of Postoperative C. difficile Infections | To evaluate the effects of oral antibiotics on the incidence of postoperative C. difficile infections (at 90 days). | 90 days | |
| Secondary | Incidence of Antibiotics Resistant Postoperative Infectious Complications | To evaluate the effects of oral antibiotics on the incidence of of antibiotics resistant postoperative infectious complications (at 30 days) | 30 days | |
| Secondary | 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. | 30 days | |
| Secondary | 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. | 30 days | |
| Secondary | Incremental Cost-Effectiveness Ratio | To evaluate the effects of antibiotics on the incremental cost-effectiveness ratio | Through to study completion, an average of 2 years |