Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elec… (NCT03663504) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery
Canada630 participantsStarted 2018-10-23
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is comparing no bowel prep at all versus oral antibiotics alone before colon surgery, which approach does my surgeon currently use, and how does it compare to what's being tested here?
2This is a Phase 4 trial, meaning these approaches have been used before — but since results aren't final yet, what does my doctor think the current evidence says about infection risk with each method?
3The trial is still active but no longer enrolling new patients, so could my doctor find out what preliminary findings exist that might inform my own pre-surgery preparation plan?
4If I'm having elective colon surgery, how does my doctor decide which bowel preparation method is safest for my specific situation, given factors like my overall health, the type of colon procedure I need, and my infection risk?
5Are there any reasons my surgeon would recommend a different preparation approach — like the traditional full mechanical bowel prep — instead of one of the methods being compared in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.