Clinical trial NCT03663504: Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery
Official title: A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Elective Colon Surgery
Keywords: Oral Antibiotics
Preoperative Mechanical Bowel Preparation
Surgical Site Infection
C. difficile
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-Operative Surgical Infection Complication
timeFrame: 30 days
Secondary outcomes:
measure: Grade III-IV Postoperative Surgical Site Infectious Complication
timeFrame: 30 days
measure: Postoperative Infections Complications
timeFrame: 30 days
measure: Overall Postoperative Complication Rate
timeFrame: 30 days
measure: Postoperative Length of Stay
timeFrame: Number of days spent in hospital post-operatively, average of 6 days
measure: Incidence of Postoperative C. difficile Infections
timeFrame: 90 days
measure: Incidence of Antibiotics Resistant Postoperative Infectious Complications
timeFrame: 30 days
measure: Patient Quality of Life
timeFrame: 30 days
measure: Direct Estimation of Health Utility Values
timeFrame: 30 days
measure: Incremental Cost-Effectiveness Ratio
timeFrame: Through to study completion, an average of 2 years
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: The Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: Queensway Carleton Hospital
state: Ontario
city: Renfrew
country: Canada
facility: Renfrew Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Rebecca Auer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Apte SS, Moloo H, Jeong A, Liu M, Vandemeer L, Suh K, Thavorn K, Fergusson DA, Clemons M, Auer RC. Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol. BMJ Open. 2020 Jul 9;10(7):e036866. doi: 10.1136/bmjopen-2020-036866.