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Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

NCT05334485 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-07

No results posted yet for this study

Summary

A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.

Conditions

  • Postoperative Ileus

Interventions

DRUG

Pyridostigmine Bromide

Oral 60mg pyridostigmine bromide

OTHER

Placebo

Oral starch placebo

Sponsors & Collaborators

  • Stefan Holubar MD MS FACS, FASCRS

    lead OTHER

Principal Investigators

  • Stefan D Holubar · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2026-09-30
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05334485 on ClinicalTrials.gov