None listed
Conditions
Brief summary
The setting is a multi-centre, double-blinded, randomised controlled trial comparing standard unit preparation with and without oral antibiotics in adult patients undergoing elective colorectal surgery with a planned anastomosis. One group will receive OAB and the other an identical appearing placebo capsules. The observational sub-study will comprise patients who will provide samples for microbiome analysis. This will include four groups of 15 patients who will receive different types of bowel preparation and an analysis of patients with anastomotic leaks and matched controls.
Interventions
This observational sub-study is occurring as part of a randomised controlled trial (registered as ACTRN12622000285752) where participants are randomised to oral antibiotics (OAB) or placebo in addition to routine care as part of the participating patient's bowel preparation on the day before surgery. Broad spectrum Intravenous antibiotics (IV) will be administered according to individual hospital guidelines. IV antibiotics administered will have adequate aerobic and anaerobic antimicrobial cover
This observational sub-study is occurring as part of a randomised controlled trial (registered as ACTRN12622000285752) where participants are randomised to oral antibiotics (OAB) or placebo in addition to routine care as part of the participating patient's bowel preparation on the day before surgery. Broad spectrum Intravenous antibiotics (IV) will be administered according to individual hospital guidelines. IV antibiotics administered will have adequate aerobic and anaerobic antimicrobial coverage. The use of mechanical bowel preparation (MBP) and enemas will be determined according to individual hospital guidelines. The exposure to OAB will be randomised according to the parent trial protocol. OAB Group 1. Standard pre-operative preparation for surgery, including the decision to use MBP or not, as per institutional protocol 2. OAB: 1 g neomycin and 400 mg metronidazole PO at 13:00, 14:00 and 20:00 on the day before surgery. No laboratory test will be used to monitor adherence. The observational sub-study involves the additional collection of rectal swabs on the day before surgery, in theatre, five days postoperative or discharge whichever is sooner. For those that develop an anastomotic leak, a swab of the anastomosis will be taken at the time of treatment for the leak.
Sponsors
Otago University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective colorectal resection with primary anastomosis – this includes open, laparoscopic, or robotic resections. 2. Above the age of 18
Exclusion criteria
1. Emergency surgery 2. Allergy to metronidazole or neomycin 3. Has received antibiotics in the preceding month before first sample collection 4. Pregnancy 5. Inability to consent 6. Post-Randomisation exclusion: No anastomosis performed 7. Patients having surgery with a rectal anastomosis will have swabs 1 and 2 performed, but will be excluded from having swabs 3 and 4 done.
Outcome results
None listed