RecruitingPhase 3ACTRN12621000530820

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.


Sponsor

The University of Adelaide

Enrollment

130 participants

Start Date

Oct 7, 2021

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After bowel surgery, it is very common for the bowel to temporarily stop working — a complication called post-operative ileus. This can leave patients feeling bloated, nauseous, and unable to eat or drink, often extending their hospital stay significantly. Current recovery protocols have limited tools to speed up the return of normal bowel function. This trial tests whether adding a medication called pyridostigmine — which stimulates nerve signals to the gut — to the standard post-surgical recovery protocol can shorten the duration of post-operative ileus. You may be eligible if you are 18 or older, are scheduled for elective large or small bowel surgery (including reversal of a Hartmann's procedure or stoma formation) at the Central Adelaide Local Health Network, and are able to give consent. Exclusion criteria include a range of heart, neurological, or respiratory conditions, as well as pregnancy. This is a double-blind randomised controlled trial — neither you nor your doctors will know which treatment you are receiving until the study ends. The main outcome measured is how quickly normal bowel function returns after surgery. If effective, pyridostigmine could become a routine part of enhanced recovery protocols for bowel surgery patients.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 ed

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.


Locations(2)

The Royal Adelaide Hospital - Adelaide

SA, Australia

St Andrew's Hospital Inc - Adelaide

SA, Australia

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ACTRN12621000530820