Effect of pyridostigmine on the duration of post-operative ileus after colorectal surgery.
PyRICo-RCT – The effect of Pyridostigmine to Reduce the duration of post-operative Ileus after Colorectal Surgery in adults – a double-blinded Randomised Controlled Trial.
The University of Adelaide
130 participants
Oct 7, 2021
Interventional
Conditions
Summary
After abdominal surgery, the bowel can commonly be paralysed and slow to return to normal function. The resultant intolerance to food and liquids can result in severe bloating, inability to pass a bowel movement or gas, nausea, and vomiting. This complication of surgery is called post-operative ileus and is a source of discomfort for patients after surgery. In colorectal rectal surgery, this common complication results in the second most morbidity and mortality following an anastomotic leak and doubles the cost of an admission. This study is a double blinded randomised controlled trial to determine if pyridostigmine can be included as part of an enhanced recovery protocol (ERP) to reduce the duration of post-operative ileus following colorectal surgery.
Eligibility
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Interventions
Study participants will be undergo standard peri-operative care as per our current enhanced recovery protocol (ERP). The ERP is standardised to the Royal Adelaide hospital, involving preoperatively educating patients, minimising the amount of bowel preparation, minimal fasting, carbohydrate and immunonutrition drinks. Intraoperatively this protocol aims for euvolemia, antibiotic prophylaxis as per guidelines, antiemetics, opioid sparing, multimodal analgesia and regional blocks where appropriate. Intraoperatively we also aim to avoid hypoxia and hypothermia along with achieving minimally invasive surgery if possible. Postoperatively oral intake, multimodal analgesia, mobilising, DVT prophylaxis, antiemetic therapy and IV therapy is guided by the protocol. In addition patients are randomised to receive either pyridostigmine or placebo. Drug: Pyridostigmine bromide. Dose: 60 mg twice daily. Mode of administration: Oral tablet, blinded from patient and administrating staff by being encapsulated. Duration: Administered from six hours following surgery, until passage of first stool. Drug adherence: Pyridostigmine/placebo will be administered via blinded staff and recorded in the patients electronic medical records.
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ACTRN12621000530820