Pyridostigmine to reduce the duration of postoperative Ileus in patients undergoing colorectal surgery

Phase 2

Recruiting

• Conditions: Postoperative Ileus; Postoperative Complications; Colorectal Surgery; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620001262998
• Lead Sponsor: The Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-24
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br><br>30-day postoperative complication rate (Clavien-Dindo graded) <br><br>[From the date of surgery until 30 days postoperatively (in days)];Duration of Post-operative ileus (POI) measured using a validated composite outcome measure GI-2: the interval from surgery until the 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 telephonically if they did not achieve their primary outcome at discharge];Reported adverse events [From the date of surgery until 30 days postoperatively (in days). Patients will be reviewed twice per day from the date of surgery until discharge from hospital (in days) and this outcome would be assessed by clinical assessment of participants post-surgery. Examples of adverse events - severe allergic rash due to the medication, exacerbated side-effects of the medication.]