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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

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

Condition or disease Intervention/treatment Phase
Elective Colon Surgery Other: No Preparation Drug: Neomycin and Flagyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Study Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery (REaCT-NSQIP)
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : September 4, 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: Metronidazole




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Overall Postoperative Complication Rate [ Time Frame: 30 days ]
    To evaluate the effects of oral antibiotics on overall postoperative complication rate (at 30 days).

  4. 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).

  5. 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).

  6. 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)

  7. 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.

  8. 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.

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663504


Contacts
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Contact: Lisa Vandermeer 613-737-7700 ext 73039 lvandermeer@toh.ca
Contact: Ahwon Jeong 613-737-7700 ext 79150 ajeong@ohri.ca

Locations
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Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8M2
Principal Investigator: Rebecca Auer, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Rebecca Auer, MD Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03663504    
Other Study ID Numbers: OTT 18-03
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Oral Antibiotics
Preoperative Mechanical Bowel Preparation
Surgical Site Infection
C. difficile
Additional relevant MeSH terms:
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Metronidazole
Neomycin
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action