Oral Antibiotics vs. No Prep for Colon Resection Surgery

(REaCT-NSQIP Trial)

Recruiting at 6 trial locations

Overseen By Danielle Allard

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Metronidazole, Neomycin

Disqualifiers: Rectal resection, Emergency surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

630 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether taking oral antibiotics (neomycin and Flagyl) before colon surgery is more effective than no preparation. It seeks to identify which method aids better recovery and reduces complications after surgery. Suitable candidates for this trial are those scheduled for elective colon surgery who do not require special bowel prep, as determined by their surgeon. As a Phase 4 trial, this research explores how an FDA-approved and proven treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that taking oral antibiotics like Neomycin and Flagyl (Metronidazole) before colorectal surgery can be safe for patients. Studies have found that this combination lowers the risk of wound infections and bacterial complications after surgery.

Most people tolerate these antibiotics well. However, like any medication, they can cause side effects. Some individuals might experience mild stomach issues, such as nausea or diarrhea, but serious side effects are rare.

Using these antibiotics before surgery is a common practice, and they have been safely used for many years, demonstrating their reliability in preventing infections in medical settings. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the trial comparing oral antibiotics to no preparation for colon resection surgery because it challenges the current standard, which typically involves bowel preparation to reduce infection risk. Neomycin and Flagyl, the oral antibiotics in question, are being tested for their potential to prevent infections when taken the day before surgery, possibly offering a simpler, less invasive alternative to traditional methods. This approach could lead to easier preparation for patients, reducing the discomfort and complications associated with conventional bowel prep routines.

What evidence suggests that this trial's treatments could be effective for preoperative bowel preparation in colorectal surgery?

This trial will compare the use of oral antibiotics with no preparation before colon resection surgery. Studies have shown that taking oral antibiotics such as Neomycin and Flagyl before colon surgery reduces the risk of infections. Research indicates that these antibiotics lower the chances of wound infections and other bacterial issues. Taking these antibiotics the day before surgery can lead to fewer infections at the surgery site. This method appears to prepare the bowel effectively, helping to prevent post-surgery complications. Overall, using antibiotics in this context has been linked to better outcomes in colon surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Sameer Apte, MD

Principal Investigator

The Ottawa Hospital

Rebecca Auer, MD

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can verbally agree to participate.

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

Exclusion Criteria

I am scheduled for surgery to remove part of my rectum and reconnect the ends.

I am allergic or have had bad reactions to certain oral antibiotics.

I needed emergency surgery without time for pre-surgery oral antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Participants receive either no preparation or oral antibiotics (neomycin and flagyl) the day before surgery

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo elective colorectal surgery and receive immediate postoperative care

6 days

Inpatient stay

Follow-up

Participants are monitored for postoperative complications, quality of life, and other outcomes

30 days

2 visits (in-person)

Extended Follow-up

Participants are monitored for incidence of C. difficile infections and other long-term outcomes

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Neomycin and Flagyl
• No Preparation

Trial Overview 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.

How Is the Trial Designed?

Group I: No Preparation Active Control 1 Intervention

No preparation before surgery

Group II: Oral Antibiotics Active Control 1 Intervention

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

Neomycin and Flagyl is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neomycin and Metronidazole for:

• Prevention of surgical site infections in colorectal surgery

Approved in European Union as Neomycin and Metronidazole for:

• Prevention of surgical site infections in colorectal surgery

Approved in Canada as Neomycin and Metronidazole for:

• Prevention of surgical site infections in colorectal surgery
• Note: Neomycin is not commercially available in oral formulation in Canada.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

In a study of 194 patients undergoing elective colorectal surgery, those who received only oral antibiotics (neomycin and erythromycin) had a significantly higher rate of postoperative septic complications (27.4%) compared to those receiving systemic metronidazole and gentamicin (11.9%) or both oral and systemic antibiotics (12.3%).

The results suggest that systemic metronidazole and gentamicin are effective in reducing the risk of postoperative sepsis, and combining oral and systemic antibiotics does not provide additional benefits, indicating that systemic antibiotics should be preferred in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic antibiotics in elective colorectal surgery. Lau, WY., Chu, KW., Poon, GP., et al.[2022]

In a study of 120 patients undergoing elective colorectal surgery, adding oral neomycin and metronidazole to bowel preparation significantly reduced the rates of wound sepsis, septicaemia, and anastomotic dehiscence, highlighting its efficacy in preventing infections (P < 0.01 for wound sepsis, P < 0.02 for both septicaemia and anastomotic dehiscence).

The use of an elemental diet did not provide any advantages over standard mechanical bowel preparation, suggesting that traditional methods remain effective for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized multicentre trial of oral bowel preparation and antimicrobials for elective colorectal operations. Matheson, DM., Arabi, Y., Baxter-Smith, D., et al.[2019]

A significant majority (83.2%) of U.S. colorectal surgeons now routinely use oral antibiotics before elective colorectal surgery, reflecting a shift towards current literature recommendations after a decline in previous years.

Most surgeons also combine oral antibiotics with mechanical bowel preparation (98.6%) and parenteral antibiotics (79.3%), indicating a comprehensive approach to pre-operative care that aims to enhance patient safety and surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current U.S. Pre-Operative Bowel Preparation Trends: A 2018 Survey of the American Society of Colon and Rectal Surgeons Members. McChesney, SL., Zelhart, MD., Green, RL., et al.[2020]

In a study of 73 patients undergoing elective colonic resection, the combination of oral neomycin and metronidazole significantly reduced the incidence of wound infections to 22%, compared to 51% with metronidazole alone (P<0.02).

The combination treatment also led to a significant decrease in anaerobic infections, suggesting that oral metronidazole should always be paired with oral neomycin for effective infection prevention in these surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of adding neomycin to metronidazole for bowel preparation. Vallance, S., Jones, B., Arabi, Y., et al.[2022]

In a study involving 396 patients undergoing colon resection, mechanical and oral antibiotic bowel preparation (MOABP) did not significantly reduce surgical site infections (SSIs) compared to no bowel preparation (NBP), with 7% of the MOABP group and 11% of the NBP group experiencing SSIs.

The findings suggest that current recommendations for routine use of MOABP to lower SSIs and morbidity in colon surgery should be reconsidered, as there was no significant difference in overall complications or mortality between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical and oral antibiotic bowel preparation versus no bowel preparation for elective colectomy (MOBILE): a multicentre, randomised, parallel, single-blinded trial. Koskenvuo, L., Lehtonen, T., Koskensalo, S., et al.[2021]

In a study of 88 patients undergoing elective bowel resection, conventional bowel preparation methods did not significantly alter the colonic microflora, indicating their safety in terms of microbial balance.

The addition of oral neomycin and metronidazole to any bowel preparation method resulted in a significant reduction of harmful bacteria like E. coli and Bacteroides fragilis, suggesting enhanced efficacy in controlling colonic bacteria before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of bowel preparation and antimicrobials on colonic microflora. Arabi, Y., Dimock, F., Burdon, DW., et al.[2019]

The use of Metronidazole and Neomycin for preoperative bowel preparation, combined with a low residue diet, significantly reduced the rate of wound infections from 45% to 10% in elective surgeries.

This prospective study highlights the efficacy of this bowel preparation regimen in improving surgical outcomes by minimizing infection risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Wound infection prophylaxis in colonic and rectal surgery with metronidazole and neomycin--a prospective study]. Nowak, W., Erbe, HJ.[2018]

In a study of 68 patients undergoing elective colorectal surgery, the combination of 1-day mechanical bowel preparation with 10% mannitol, oral neomycin, and intravenous Flagyl resulted in a 0% septic complication rate, compared to a 22% rate in the placebo group.

The treatment was found to be safe, with no complications from the mannitol solution or intravenous Flagyl, highlighting its efficacy in reducing septic complications during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized, double-blind study of 10% mannitol mechanical bowel preparation combined with oral neomycin and short-term, perioperative, intravenous Flagyl as prophylaxis in elective colorectal resections. Jagelman, DG., Fazio, VW., Lavery, IC., et al.[2018]

In a study involving 31 patients (7 adults and 24 children) undergoing bowel preparation for colorectal surgery, the combination of mechanical washout with oral neomycin and metronidazole significantly reduced postoperative infection rates to 6%, compared to 40-46% in other preparation methods.

The study highlights the effectiveness of using both antibiotics against aerobes and anaerobes in conjunction with mechanical preparation, suggesting this combination is the safest and most effective approach for bowel preparation before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical studies of 4 methods of bowel preparation in colorectal surgery. Debo Adeyemi, S., Tai da Rocha-Afodu, J.[2019]

In a study of 100 patients undergoing elective colonic resections, those who received bowel preparation with Neomycin alone (group A) experienced 17 bacterial inflammatory complications, compared to only 10 complications in those who received Neomycin combined with Metronidazole (group B).

The results suggest that adding Metronidazole, an antianaerobic antibiotic, to the bowel preparation regimen may reduce the risk of bacterial inflammatory complications during elective colonic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neomycin versus plus metronidazol for large bowel preparation in elective colon surgery]. Barone, C., Hell, K.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6570620/

The Role of Oral Antibiotic Preparation in Elective ... Neomycin 1 g every 6 h and metronidazole 200 mg every 8 h for 24 h prior to surgery. Mannitol 100 g in 1 L water the day before surgery. Metronidazole 500 mg at ...

2. withpower.com withpower.com/trial/phase-4-9-2018-e1132

Oral Antibiotics vs. No Prep for Colon Resection Surgery Research shows that adding Neomycin and Metronidazole to bowel preparation significantly reduces wound infections and bacterial complications during colon ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03663504

Comparing No Mechanical Bowel Preparation With Oral ... To evaluate that use of oral antibiotics (neomycin and flagyl), administered the day prior to elective colonic resection is associated with a significant ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9854941/

Preoperative oral fluoroquinolone antibiotics in elective ... Preoperative treatment with oral neomycin combined with erythromycin or metronidazole is recommended to decrease the risk of surgical site ...

5. sciencedirect.com sciencedirect.com/topics/nursing-and-health-professions/colon-surgery

Colon Surgery - an overview | ScienceDirect Topics The use of oral antibiotics (erythromycin and neomycin) has traditionally been recommended to reduce infectious complications following colonic surgery. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10412473/

Oral antibiotics and mechanical bowel preparation for ... In conclusion, the combination OAB metronidazole and neomycin with MBP before major colorectal surgery seems to be related to a decrease in SSI ...

7. ashp.org ashp.org/surgical-guidelines

Clinical Practice Guidelines for Antimicrobial Prophylaxis in ... 2,3 The guidelines are in- tended to provide practitioners with a standardized approach to the rational, safe, and effective use of antimicrobial agents for the ...