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Antibiotics

Oral Antibiotics vs. No Prep for Colon Resection Surgery (REaCT-NSQIP Trial)

Phase 4

Recruiting

Led By Rebecca Auer, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing elective, non-emergency colon resection surgery or abdominal perineal resection with no other requirements for a mechanical bowel preparation (as determined by the operating surgeon)

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through to study completion, an average of 2 years

Awards & highlights

REaCT-NSQIP Trial Summary

This trial will compare the two standard treatments for prepping the bowel before colorectal surgery: oral antibiotics vs. no antibiotics.

Who is the study for?

This trial is for adults who need elective, non-emergency colon surgery and don't require mechanical bowel preparation as decided by their surgeon. They must be able to give oral consent. It's not for those with allergies to the antibiotics metronidazole or neomycin, needing emergency surgery, or certain types of rectal resections.Check my eligibility

What is being tested?

The study compares two preoperative treatments before colorectal surgery: one group will receive oral antibiotics (Neomycin and Flagyl), while the other group won't get any preparation. The goal is to see which method is better.See study design

What are the potential side effects?

Possible side effects from Neomycin and Flagyl may include stomach upset, diarrhea, nausea, a metallic taste in the mouth, dizziness, and potential allergic reactions.

REaCT-NSQIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for planned colon surgery without the need for a special bowel prep.

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I am 18 years old or older.

REaCT-NSQIP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through to study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through to study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through to study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Communicable Diseases

Secondary outcome measures

Direct Estimation of Health Utility Values

Pregnancy Complications, Infectious

Antibiotics

+6 more

REaCT-NSQIP Trial Design

2Treatment groups

Active Control

Group I: No PreparationActive Control1 Intervention

No preparation before surgery

Group II: Oral AntibioticsActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,259 Total Patients Enrolled

Rebecca Auer, MDPrincipal InvestigatorOttawa Hospital Research Institute

Media Library

Neomycin and Flagyl (Antibiotics) Clinical Trial Eligibility Overview. Trial Name: NCT03663504 — Phase 4

Colon Resection Surgery Research Study Groups: No Preparation, Oral Antibiotics

Colon Resection Surgery Clinical Trial 2023: Neomycin and Flagyl Highlights & Side Effects. Trial Name: NCT03663504 — Phase 4

Neomycin and Flagyl (Antibiotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03663504 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions is No Preparation primarily used to treat?

"No Preparation can be employed to cure an infant's cradle cap as well as conditions like diarrhea, bacterial infections, and candidal vulvovaginitis."

Answered by AI

How many participants are being administered the treatment in this clinical trial?

"Affirmative, the clinical trial is actively recruiting. According to clinicaltrials.gov, this research was first posted on October 23rd 2018 and most recently edited on April 19th 2022. 432 participants are required across a single location for this study's completion."

Answered by AI

What are the safety implications of No Preparation on human health?

"This treatment has been approved, resulting in a score of 3 on our scale from 1 to 3 for the safety of No Preparation."

Answered by AI

Is this research study still open to additional participants?

"As evidenced on clinicaltrials.gov, this trial is actively looking for qualified participants with the study being published as early as October 23rd of 2018 and last updated on April 19th 2022."

Answered by AI

Recent research and studies

BMJ OpenJournal

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

Apte, Sameer S, Husein Moloo, Ahwon Jeong, Michelle Liu, Lisa Vandemeer, Kathryn Suh, Kednapa Thavorn, Dean A Fergusson, Mark Clemons, and Rebecca C Auer. 2020. “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. BMJ. doi:10.1136/bmjopen-2020-036866.

clinicaltrials.govStudy

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

2018. "Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03663504.