None listed
Conditions
Brief summary
Post-operative ileus (POI) is characterized by impairment of bowel motility and is a common complication after major abdominal surgery in general, and after colorectal surgery in particular. The principal features of POI include nausea and vomiting, inability to tolerate diet, significant abdominal distension and delayed passage of flatus and stool. POI as a complication has the largest overall effect on length of postoperative hospitalization. The purpose of this phase II trial is to determine the safety and effectiveness of oral pyridostigmine after elective colorectal surgery. We hypothesise that, within an optimised Enhanced Recovery Protocols (ERPs) setting, giving oral pyridostigmine to patients post-operatively will result in a reduction in the duration of postoperative Ileus.
Interventions
Study participants will receive standard peri-operative care as per our current Enhanced recovery protocol (ERP) but with the addition of
Name: Pyridostigmine bromide
Dose: 60 mg twice a day
Duration: From the day of surgery, six hours after the operation until the passage of stool
Mode of administration: Oral tablet
Adherence to the intervention would be monitored by routine checking of medication administration charts
Sponsors
The Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adult patients (aged 18 or older) from Central Adelaide Local Health Network catchment area - Undergoing elective colorectal surgery (including large or small bowel resections for any indication or undergoing reversal of Hartmann's or loop-ileostomy closure or formation of a stoma - Able to give informed consent
Exclusion criteria
Under 18 years of age. Pregnancy Previous adverse reaction to pyridostigmine ASA >=4 due to the higher likelihood or morbidity and mortality, which may confound resulting data. Active inflammatory bowel disease Prolonged QT syndrome (greater than 0.43sec for males, 0.45 for females) Medications that are prescribed directly for their anti-cholinergic effects (e.g. Glycopyrrolate for drooling; amitriptyline for loose bowel actions); Asthma requiring regular medications Ischaemic heart disease or cardiac arrhythmias within the previous 12 months History of epilepsy History of Parkinson’s disease Hyperthyroidism Peptic ulcer disease Diagnosed pelvic disorders that may be a cause of constipation Moderate to severe renal impairment Creatinine clearance of < 30 ml/min CrCl ml/min = [140-age(years)] x bodyweight (kg) / R x serum creatinine (micromol/L) R = 0.815 for males, 0.85 for females History of bowel obstructions, strictures or history of any diseases affecting bowel transit (e.g. uncontrolled hypothyroidism, hypercalcaemia), irritable bowel syndrome (IBS), history of faecal incontinence) Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment and/or language barrier.
Outcome results
None listed