Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)

Ottawa Hospital Research Institute

Status and phase: Active, not recruiting; Phase 4

Conditions: Elective Colon Surgery

Treatments: Drug: Neomycin and Flagyl; Other: No Preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT03663504

REaCT-NSQIP (Other Identifier)

OTT 18-03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 630 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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630 participants in 2 patient groups

No Preparation

Active Comparator group

Description:

No preparation before surgery

Treatment:

Other: No Preparation

Oral Antibiotics

Active Comparator group

Description:

Oral antibiotics (neomycin and flagyl), to be taken the day before the surgery

Treatment:

Drug: Neomycin and Flagyl