Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT05334485

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Led by Stefan Holubar MD MS FACS, FASCRS · Updated on 2026-01-07

50

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 and over with benign or malignant colonic or rectal disease
  • Patients who underwent elective laparoscopic, robotic, or open colorectal resections with or without ostomy
  • Development of postoperative ileus with bloating, possible nausea/vomiting, and no passage of flatus or stool for at least 48 hours
  • Need to return to NPO status after initial diet attempts, with or without nasogastric tube placement
  • Radiographic confirmation of postoperative ileus by abdominal X-ray or CT scan
  • ECOG Performance status less than 4
  • Normal organ function shown by laboratory tests including hemoglobin ≥ 7.0 g/dL, WBC between 4,000 and 20,000/mcL, platelet count ≥ 100,000/mcL, liver enzymes within 2.5 times upper normal limits, normal bilirubin and creatinine levels
Not Eligible

You will not qualify if you...

  • Evidence of bowel obstruction on imaging
  • Presence of intraabdominal septic complications such as abscess, peritonitis, or anastomotic leak before or after enrollment
  • Surgery involving only small bowel or ostomy without colon or rectal resection
  • ASA score of 5
  • Pregnant or breastfeeding females
  • Current use of investigational agents or specific medications like neostigmine, alvimopan, metoclopramide, erythromycin, methylnaltrexone, naloxegol, cisapride, or laxatives
  • History of allergic reactions to pyridostigmine or similar drugs
  • Uncontrolled illnesses including myasthenia gravis, asthma/reactive airway disease, COPD, symptomatic heart failure, unstable angina, cardiac arrhythmia, renal or hepatic failure, gastroparesis, short bowel syndrome, bowel motility disorders, chronic constipation with laxative use, peritoneal carcinomatosis, or psychiatric/social issues limiting study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic Main Campus

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

S

Stefan D Holubar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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