Not Yet RecruitingPhase 2ACTRN12621000254897

Efficacy of oral pyridostigmine for the treatment of acute colonic pseudo-obstruction - a prospective, randomized, placebo-controlled trial.

Efficacy of oral pyridostigmine for the treatment of acute colonic pseudo-obstruction in adults - a prospective, randomized, placebo-controlled trial.


Sponsor

Eastern Health - Box Hill Hospital

Enrollment

40 participants

Start Date

Apr 1, 2021

Study Type

Interventional

Conditions

Summary

This trial aims to investigate the efficacy of oral pyridostigmine, a medication currently used to treat Myasthenia Gravis, in the treatment of acute colonic pseudo-obstruction (ACPO). Acute colonic pseudo-obstruction occurs when the large intestine becomes dilated in the absence of downstream mechanical obstruction, and often occurs in the setting of hospitalized patients who are non-mobile, and/or are on significant amounts of opioid medications. Current treatment options for ACPO include the use of medications such as intravenous neostigmine, which is effective but requires cardiac monitoring due to the risk of cardiac arrhythmias, endoscopic decompression, or surgery. A recently published case series has suggested that oral pyridostigmine is effective in treating patients with ACPO, without the need for cardiac monitoring, unlike neostigmine. However, strong evidence in this field is still lacking, which this study aims to help address.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Adult patients with acute colonic pseudo-obstruction confirmed on imaging (plain abdominal radiograph, computed tomography, or magnetic resonance imaging) in whom a distal colonic obstruction has been ruled out via a rigid sigmoidoscopy.

Exclusion Criteria4

  • Patients with known adverse reaction to pyridostigmine.
  • Patients with signs of abdominal peritonism.
  • Patients currently already on oral pyridostigmine.
  • Patients

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Interventions

Oral pyridostigmine 10mg two times a day for up to 48 hours or until bowels open, whichever earlier. Medication will be administered by nursing staff on the wards, as the trial participants will be cu

Oral pyridostigmine 10mg two times a day for up to 48 hours or until bowels open, whichever earlier. Medication will be administered by nursing staff on the wards, as the trial participants will be current inpatients. Inpatient medical records will provide evidence of medication administration.


Locations(3)

Box Hill Hospital - Box Hill

VIC, Australia

Maroondah Hospital - Ringwood East

VIC, Australia

Angliss Hospital - Upper Ferntree Gully

VIC, Australia

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ACTRN12621000254897