Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)
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|ClinicalTrials.gov Identifier: NCT03663504|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Elective Colon Surgery||Other: No Preparation Drug: Neomycin and Flagyl||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||September 4, 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: No Preparation
No preparation before surgery
Other: No Preparation
No preparation before surgery
Active Comparator: Oral Antibiotics
Oral antibiotics (neomycin and flagyl), to be taken the day before the surgery
Drug: Neomycin and Flagyl
Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery
Other Name: Metronidazole
- Post-Operative Surgical Infection Complication [ Time Frame: 30 days ]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).
- Grade III-IV Postoperative Surgical Site Infectious Complication [ Time Frame: 30 days ]To evaluate the effects of oral antibiotics on Grade III-IV (Clavien-Dindo classification) postoperative surgical site infectious complication (at 30 days).
- Postoperative Infections Complications [ Time Frame: 30 days ]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).
- Overall Postoperative Complication Rate [ Time Frame: 30 days ]To evaluate the effects of oral antibiotics on overall postoperative complication rate (at 30 days).
- Postoperative Length of Stay [ Time Frame: Number of days spent in hospital post-operatively, average of 6 days ]To evaluate the effects of oral antibiotics on postoperative length of stay (LOS).
- Incidence of Postoperative C. difficile Infections [ Time Frame: 90 days ]To evaluate the effects of oral antibiotics on the incidence of postoperative C. difficile infections (at 90 days).
- Incidence of Antibiotics Resistant Postoperative Infectious Complications [ Time Frame: 30 days ]To evaluate the effects of oral antibiotics on the incidence of of antibiotics resistant postoperative infectious complications (at 30 days)
- Patient Quality of Life [ Time Frame: 30 days ]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.
- Direct Estimation of Health Utility Values [ Time Frame: 30 days ]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.
- Incremental Cost-Effectiveness Ratio [ Time Frame: Through to study completion, an average of 2 years ]To evaluate the effects of antibiotics on the incremental cost-effectiveness ratio
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663504
|Contact: Lisa Vandermeer||613-737-7700 ext firstname.lastname@example.org|
|Contact: Ahwon Jeong||613-737-7700 ext email@example.com|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1H 8M2|
|Principal Investigator: Rebecca Auer, MD|
|Principal Investigator:||Rebecca Auer, MD||Ottawa Hospital Research Institute|