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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-06
• Last Update Posted: 26 September 2023

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

Name	Time	Method
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.]