Mechanical Bowel Prep Randomized Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada

About this trial

Following colon surgery, surgical site infection (SSI) is the most common complication and leads to longer recovery time for patients and increased health care costs. Currently, there is high quality evidence to show that the combination of intravenous antibiotics (IVA), mechanical bowel preparation (MBP) and oral antibiotics (OA) is the most effective bowel preparation to reduce SSI. However, there are no studies comparing IVA+MBP+OA and IVA+OA. This is an important question because if IVA+OA works the same as IVA+MBP+OA, then MBP may be safely omitted as part of the bowel preparation to reduce SSI and patients would avoid the side effects of MBP prior to their surgery. Therefore, the objective is to perform a trial to determine if IVA+OA works the same as IVA+MBP+OA to reduce SSI following colon surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

undergoing elective colon surgery for benign or malignant disease

over the age of 18 years

provides informed consent.

Disqualifiers

known anaphylaxis to neomycin or metronidazole

pregnancy or lactation

chronic renal failure (serum creatinine > 220 umol/L).

Trial design

Design model

Parallel

Treatments tested in this trial

  • IVA+OA versus IVA+MBP+OA

    Other intervention

    Non-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery

Treatment groups

1,062 Participants
are divided into 2 treatment groups
Group A: Group A: IV and Oral antibiotics (IVA+OA)Active comparator 1 intervention
Group B: Group B: IV antibiotics, MBP and oral antibiotics (IVA+MBP+OA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical Site Infection Rate

Rate of overall surgical site infection

Time frame
30 days following date of surgery

Secondary outcomes

1

Patient tolerability of the bowel preparation

Validated 9-item questionnaire entitled: "Mayo Clinic Bowel Prep Tolerability Questionnaire" (Scale 1-4; lower score = better outcome)

Time frame
5 minutes (completed in pre-operative holding area on the day of surgery)
2

Length of stay

length of stay in hospital following colorectal procedure

Time frame
2-7 days
3

30-day ER rate

emergency room visit rate to any hospital within 30 days of surgery

Time frame
30 days
4

30-day readmission rate

readmission rate to any hospital within 30 days of surgery

Time frame
30 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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