Pyridostigmine to reduce the duration of postoperative Ileus in patients undergoing colorectal surgery
PyRICo-P – Pyridostigmine to Reduce the duration of postoperative Ileus after Colorectal Surgery – a Phase II study.
The Royal Adelaide Hospital
15 participants
Sep 17, 2020
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria19
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
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
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12620001262998