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

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

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

Study Overview

• Status: Recruiting
• Conditions: Elective Colon Surgery
• Intervention / Treatment: Other: No Preparation; Drug: Neomycin and Flagyl

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.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lisa Vandermeer; Phone Number: 73039 613-737-7700; Email: lvandermeer@toh.ca
• Study Contact Backup: Name: Michelle Liu; Phone Number: 79150 613-737-7700; Email: miliu@ohri.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Recruiting
      • The Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8M2
      • Recruiting
      • The Ottawa Hospital Cancer Centre
      • Principal Investigator: Rebecca Auer, MD
    • Ottawa, Ontario, Canada, K2H 8P4
      • Recruiting
      • Queensway Carleton Hospital
    • Renfrew, Ontario, Canada, K7V 1P6
      • Recruiting
      • Renfrew Victoria Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Not yet recruiting
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Surgical Infection Complication	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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade III-IV Postoperative Surgical Site Infectious Complication	To evaluate the effects of oral antibiotics on Grade III-IV (Clavien-Dindo classification) postoperative surgical site infectious complication (at 30 days).	30 days
Postoperative Infections Complications	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).	30 days
Overall Postoperative Complication Rate	To evaluate the effects of oral antibiotics on overall postoperative complication rate (at 30 days).	30 days
Postoperative Length of Stay	To evaluate the effects of oral antibiotics on postoperative length of stay (LOS).	Number of days spent in hospital post-operatively, average of 6 days
Incidence of Postoperative C. difficile Infections	To evaluate the effects of oral antibiotics on the incidence of postoperative C. difficile infections (at 90 days).	90 days
Incidence of Antibiotics Resistant Postoperative Infectious Complications	To evaluate the effects of oral antibiotics on the incidence of of antibiotics resistant postoperative infectious complications (at 30 days)	30 days
Patient Quality of Life	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.	30 days
Direct Estimation of Health Utility Values	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.	30 days
Incremental Cost-Effectiveness Ratio	To evaluate the effects of antibiotics on the incremental cost-effectiveness ratio	Through to study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Rebecca Auer, MD, Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surgical Site Infection; C. difficile; Oral Antibiotics; Preoperative Mechanical Bowel Preparation
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Neomycin
• Other Study ID Numbers: OTT 18-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No