Not Yet RecruitingPhase 2ACTRN12622000285752

Colorectal Anastomosis and Bacterial Eradication (CABE) Trial: The effect of pre-operative oral antibiotics on Anastomotic Leaks in Colorectal Surgery

Colorectal Anastomosis and Bacterial Eradication (CABE) Trial: The effect of pre-operative antibiotics on Anastomotic Leaks in Colorectal Surgery

Sponsor

Mr Asiri Arachchi

Enrollment

4,000 participants

Start Date

Nov 1, 2024

Study Type

Interventional

Conditions

Respiratory infections Mortality Surgical Site Infections Gastrointestinal infections

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Patients undergoing elective open or laparoscopic colorectal resection
Able to give informed consent
Male or female patients 18 years of age or older, with no maximum

Exclusion Criteria4

Emergency Surgery
Allergy to oral antibiotics
Inability to consent
Pregnancy

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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 - ea

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.