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

Post-operative complications

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

Inclusion Criteria4

Patients over 18 years of age
Undergoing treatment from Central Adelaide Local Health Network
Able to consent
Undergoing elective large or small bowel resection for any indication or undergoing reversal of Hartmann’s or loop ileostomies or formation of stoma procedure will be invited to participate in this study.

Exclusion Criteria17

Under 18 years of age.
Pregnancy
ASA >=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data.
Residual active inflammatory bowel disease expected after surgery
Prolonged QT syndrome (>0.43sec for males, >0.45 for females)
Known adverse reaction to pyridostigmine
Prescribing anticholinergic medications (e.g. Glycopyrrolate for drooling; amitriptyline for loose bowel actions);
Asthma requiring regular medications (e.g. due to risk of exacerbation)
Ischaemic heart disease or cardiac arrhythmias within the previous 12 months
History of Epilepsy
History of Parkinson’s disease
History of Myasthenia gravis
Uncontrolled Hyperthyroidism
Active peptic ulcer disease
Moderate to severe renal impairment Creatinine clearance of < 30 ml/min
History of active disease affecting bowel transit (e.g. uncontrolled hypothyroidism, hypercalcaemia)
Unable to give consent or participate due to dementia, cognitive impairment or language barrier.

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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.