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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000254897

Acronym

OPPS-1

Enrollment

Registered

2021-03-10

Start date

2021-04-01

Completion date

2022-01-17

Last updated

2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 current inpatients. Inpatient medical records will provide evidence of medication administration.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results