Loading clinical trials...

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery (PESTI Trial)

NCT05334485•Stefan Holubar MD MS FACS, FASCRS

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Adult (age 18 and over) patients with benign or malignant colonic or rectal disease who have undergone elective laparoscopic, robotic, or open colorectal resections with or without ostomy construction at our center, and subsequently developed POI, defined as symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool for at least 48 hours postoperatively and require return to NPO status after initial diet attempts with or without placement of an NGT.
•2. Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both
•3. ECOG Performance status \< 4
•4. Laboratory evidence of normal organ function, defined as:
•1. Hemoglobin ≥ 7.0 g/dL
•2. WBC ≤ 20,000/mcL and ≥ 4,000/mcL
•3. Platelet count ≥ 100,000/mcL or ≤ 100,000,000/mcL
•4. AST (SGOT) ≤ 2.5 times the institutional upper limit of normal
•5. ALT (SGPT) ≤ 2.5 times the institutional upper limit of normal
•6. Total bilirubin within the upper limit of institutional normal range
+1 more criteria

Exclusion Criteria

•1. Radiographic evidence of bowel obstruction
•2. Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after enrollment
•3. Isolated small bowel or ostomy surgery without colon or rectal resection
•4. ASA score 5
•5. Pregnant or breastfeeding females as PYR is classified by the FDA as a pregnancy risk category C medication with the potential for teratogenic or abortifacient effects and demonstrated secretion into breastmilk with an unknown but potential risk for adverse effects in the nursing infants
•6. Current use of any other investigational agents including: neostigmine or other acetylcholine esterase inhibitors, alvimopan, metoclopramide, erythromycin, methylnaltrexone, naloxegol, cisapride, and laxatives or cathartics (i.e. milk of magnesia, polyethylene glycol)
•7. History of allergic reactions attributed to PYR or other acetylcholine esterase inhibitors
•8. Patients with any of the following uncontrolled, concurrent illnesses: active or latent MG, bronco-constrictive disease (asthma/reactive airway disease), chronic obstructive lung disease (COPD), symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia including bradycardia, renal failure, hepatic failure, gastroparesis, short bowel syndrome (small bowel \< 200cm), preexisting short or large bowel dysmotility or pseudo-obstruction, chronic constipation/laxative use, peritoneal carcinomatosis, and psychiatric illness/social situations that would limit compliance with study requirements

Locations (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Key Dates

Start Date

September 3, 2024

Primary Completion Date

September 1, 2026

Completion Date

October 1, 2026

Last Updated

January 7, 2026

Enrollment

ESTIMATED participants

Conditions

Postoperative Ileus

Interventions

Pyridostigmine Bromide

DRUG

Placebo

OTHER

Contacts

Stefan D Holubar

CONTACT

2164447000 holubas@ccf.org

The Effect of Coffee After Resection of Small Bowel

NCT03143621

Postoperative Ileus

View study

TERMINATEDNA

Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

NCT03772444

Postoperative Ileus

View study

UNKNOWNNA

Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies

NCT04675606

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Inclusion Criteria

Exclusion Criteria

The Effect of Coffee After Resection of Small Bowel

Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.

Implementing a Low Fiber Diet vs. Regular Diet in Postoperative Colorectal Patients With Ileostomies

Ileus After Lumbar Spine Surgery

Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention

Perioperative Dexamethasone on Postoperative Outcome in IBD