None listed
Conditions
Brief summary
The AWASH study aims to investigate the feasibility of applying an antibiotic wash to the bowel during surgery, with a short course of post-operative irrigation in some patients, for adults having planned colorectal surgery where the bowel is rejoined. Who is it for? You may be eligible for this study if you are an adult undergoing elective colorectal resection with primary anastomosis. Study details Participants will be randomly allocated to receive either the study treatment or standard care. The study treatment involves washing the bowel during surgery with antibiotics, and for patients undergoing an anastomosis within 15cm of the anus, a trans-anal drainage tube will be placed intra-operatively to facilitate antibiotic washing on postoperative days 1 and 2. Outcomes on success of delivery of the treatment and patient complications will be collected. It is hoped that findings from this study will help clinicians and researchers determine whether the intervention and study processes can be delivered safely and successfully to inform a larger future trial.
Interventions
Arm A: Intra-operative luminal antibiotics of 500mg in 100ml of Metronidazole with 240mg in 6ml Gentamicin. With daily post-operative antibiotic irrigation of Metronidazole 250mg (in 50ml) and Gentamicin 240mg in 6ml.
Participants in Arm A will receive an intra-operative luminal antibiotic wash administered by the treating colorectal surgeon during elective colorectal resection with primary anastomosis. After surgery, participants will receive daily antibiotic irrigation via a rectal tube for
Arm A: Intra-operative luminal antibiotics of 500mg in 100ml of Metronidazole with 240mg in 6ml Gentamicin. With daily post-operative antibiotic irrigation of Metronidazole 250mg (in 50ml) and Gentamicin 240mg in 6ml. Participants in Arm A will receive an intra-operative luminal antibiotic wash administered by the treating colorectal surgeon during elective colorectal resection with primary anastomosis. After surgery, participants will receive daily antibiotic irrigation via a rectal tube for up to 2 post-operative days, administered by an appropriately trained registered nurse and/or medical officer. Each post-operative irrigation is expected to take approximately 5–10 minutes per treatment. Adherence will be assessed using the operation note, treatment and nursing records, electronic medical record, and study case report forms documenting delivery of the intra-operative and post-operative components.
Sponsors
John Hunter hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults greater than or equal to 18 years undergoing elective colorectal resection with primary anastomosis. • Ability to provide informed consent.
Exclusion criteria
• Emergency surgery • Known allergies to antibiotics • Existence of a stoma preoperatively • Inability to provide informed consent • Pregnant and Breast-feeding women
Outcome results
None listed