NCT03663504

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Oct 2018

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Oct 2018Jul 2026

First Submitted

Initial submission to the registry

August 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

7.5 years

First QC Date

August 7, 2018

Last Update Submit

January 28, 2026

Conditions

Elective Colon Surgery

Keywords

Oral AntibioticsPreoperative Mechanical Bowel PreparationSurgical Site InfectionC. difficile

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Grade III-IV Postoperative Surgical Site Infectious Complication

    30 days

  • Postoperative Infections Complications

    30 days

  • Overall Postoperative Complication Rate

    30 days

  • Postoperative Length of Stay

    Number of days spent in hospital post-operatively, average of 6 days

  • Incidence of Postoperative C. difficile Infections

    90 days

  • +4 more secondary outcomes

Study Arms (2)

No Preparation

ACTIVE COMPARATOR

No preparation before surgery

Other: No Preparation

Oral Antibiotics

ACTIVE COMPARATOR

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

Drug: Neomycin and Flagyl

Interventions

Neomycin and FlagylDRUG

Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery

Also known as: Metronidazole
Oral Antibiotics
No PreparationOTHER

No preparation before surgery

No Preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • years of age or older
  • Able to provide oral consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8M2, Canada

Location

Hôpital Montfort

Ottawa, Ontario, K1K 0T2, Canada

Location

Queensway Carleton Hospital

Ottawa, Ontario, K2H 8P4, Canada

Location

Renfrew Victoria Hospital

Renfrew, Ontario, K7V 1P6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 32647023BACKGROUND

  • Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.

    PMID: 36748942DERIVED

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

preparation No. 012074NeomycinMetronidazole

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rebecca Auer, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Sameer Apte, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

September 10, 2018

Study Start

October 23, 2018

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

CA(6)