Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2026-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Elective Colon Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Preparation

No preparation before surgery

Group Type ACTIVE_COMPARATOR

No Preparation

Intervention Type OTHER

No preparation before surgery

Oral Antibiotics

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

Group Type ACTIVE_COMPARATOR

Neomycin and Flagyl

Intervention Type DRUG

Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery

Interventions

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No Preparation

No preparation before surgery

Intervention Type OTHER

Neomycin and Flagyl

Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery

Intervention Type DRUG

Other Intervention Names

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Metronidazole

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No