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

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ClinicalTrials.gov Identifier: NCT03663504
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE October 23, 2018
Estimated Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
Post-Operative Surgical Infection Complication [ Time Frame: 30 days ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Grade III-IV Postoperative Surgical Site Infectious Complication [ Time Frame: 30 days ]
    To evaluate the effects of oral antibiotics on Grade III-IV (Clavien-Dindo classification) postoperative surgical site infectious complication (at 30 days).
  • Postoperative Infections Complications [ Time Frame: 30 days ]
    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).
  • Overall Postoperative Complication Rate [ Time Frame: 30 days ]
    To evaluate the effects of oral antibiotics on overall postoperative complication rate (at 30 days).
  • Postoperative Length of Stay [ Time Frame: Number of days spent in hospital post-operatively, average of 6 days ]
    To evaluate the effects of oral antibiotics on postoperative length of stay (LOS).
  • Incidence of Postoperative C. difficile Infections [ Time Frame: 90 days ]
    To evaluate the effects of oral antibiotics on the incidence of postoperative C. difficile infections (at 90 days).
  • Incidence of Antibiotics Resistant Postoperative Infectious Complications [ Time Frame: 30 days ]
    To evaluate the effects of oral antibiotics on the incidence of of antibiotics resistant postoperative infectious complications (at 30 days)
  • Patient Quality of Life [ Time Frame: 30 days ]
    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.
  • Direct Estimation of Health Utility Values [ Time Frame: 30 days ]
    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.
  • Incremental Cost-Effectiveness Ratio [ Time Frame: Through to study completion, an average of 2 years ]
    To evaluate the effects of antibiotics on the incremental cost-effectiveness ratio
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery
Official Title  ICMJE A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Elective Colon Surgery
Intervention  ICMJE
  • Other: No Preparation
    No preparation before surgery
  • Drug: Neomycin and Flagyl
    Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery
    Other Name: Metronidazole
Study Arms  ICMJE
  • Active Comparator: No Preparation
    No preparation before surgery
    Intervention: Other: No Preparation
  • Active Comparator: Oral Antibiotics
    Oral antibiotics (neomycin and flagyl), to be taken the day before the surgery
    Intervention: Drug: Neomycin and Flagyl
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
432
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date September 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Vandermeer 613-737-7700 ext 73039 lvandermeer@toh.ca
Contact: Ahwon Jeong 613-737-7700 ext 79150 ajeong@ohri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03663504
Other Study ID Numbers  ICMJE OTT 18-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca Auer, MD Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP