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Effect of pyridostigmine on the duration of post-operative ileus after colorectal surgery.

Phase 3
Recruiting
Conditions
Colorectal surgery
Surgery - Other surgery
Post-operative ileus
Post-operative complications
Registration Number
ACTRN12621000530820
Lead Sponsor
The University of Adelaide
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
130
Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Duration of post-operative ileus (POI) measured using GI-2 composite score. This is a primary outcome calculated from the interval from surgery until first passage of stool AND tolerance of an oral diet.[ Patients will be reviewed twice per day from the date of surgery until discharge from hospital (in days) and then reviewed once daily via telephone if they did not achieve their primary outcome at discharge.]
Secondary Outcome Measures
NameTimeMethod
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