None listed
Conditions
Brief summary
There is convincing evidence that OAB reduces iSSI in elective colorectal surgery. However, although there is a trend in AL many of these papers have mixed results. A recent network meta-analysis Woodfield et al had elaborated the need for future high-powered studies for assessing AL in elective colorectal surgery. Currently, there are no local studies looking into the effect of pre-operative oral antibiotics as part of mechanical bowel preparation in the Australian and New Zealand context. We aim to conduct a multi-centred randomised controlled trial on the efficacy of OAB in elective colorectal resection with anastomosis and the risk of post-operative AL and iSSI. Our hypothesis is that the addition of oral antibiotics to standard care for patients undergoing elective colorectal resection will reduce anastomotic leak and incisional surgical site infections.
Interventions
Both groups will receive standard hospital care, and this may vary according to the institutional protocol used at the treatment site, but may include:
1. Osmotic laxative satchets: 3 satchets - each satchet to be drunk with 250ml of water 1 day before the operation at 1200, 1400 and 1600
2. MRSA decolononisation: 2 x (4% chlorhexidine soap packets) - patients to use shower with 1 packet night before surgery and morning of surgery. If the soap packets were used incorrectly, chlorhexidine wipes
Both groups will receive standard hospital care, and this may vary according to the institutional protocol used at the treatment site, but may include: 1. Osmotic laxative satchets: 3 satchets - each satchet to be drunk with 250ml of water 1 day before the operation at 1200, 1400 and 1600 2. MRSA decolononisation: 2 x (4% chlorhexidine soap packets) - patients to use shower with 1 packet night before surgery and morning of surgery. If the soap packets were used incorrectly, chlorhexidine wipes will be used on the day of the surgery. Intervention group – Oral antibiotics(OAB) 1. Pre-operative preparation for surgery, including decision to use Mechanical Bowel Preparation (MBP), MRSA decolonisation, both, or neither, as per institutional protocol and outlined above. 2. OAB: 1g neomycin and 400mg metronidazole at 1300, 1400 and 2000 on the preoperative day Adherence will be monitored through noting the number of tablets taken.
Sponsors
Mr Asiri Arachchi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Patients undergoing elective open or laparoscopic colorectal resection 2. Able to give informed consent 3. Male or female patients 18 years of age or older, with no maximum
Exclusion criteria
1. Emergency Surgery 2. Allergy to oral antibiotics 3. Inability to consent 4. Post-Randomisation exclusion: No anastomosis performed 5. Pregnancy
Outcome results
None listed