Cleveland, OHNCT05334485Now EnrollingIRB Ready

Postoperative Ileus Clinical Trial in Cleveland, OH

Access cutting-edge postoperative ileus treatment through this clinical trial at a research site in Cleveland. Study-provided care at no cost to qualified participants.

Sponsored by Stefan Holubar MD MS FACS, FASCRS

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Expert Care in Cleveland

Access postoperative ileus specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related postoperative ileus treatment provided free

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Check if you qualify for this postoperative ileus clinical trial in Cleveland, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cleveland

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Cleveland site if eligible
  4. 4Begin participation

About This Postoperative Ileus Study in Cleveland

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.

Sponsor: Stefan Holubar MD MS FACS, FASCRS

Who Can Participate

Inclusion Criteria

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.
Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both
ECOG Performance status \< 4
Laboratory evidence of normal organ function, defined as:
Hemoglobin ≥ 7.0 g/dL
WBC ≤ 20,000/mcL and ≥ 4,000/mcL
Platelet count ≥ 100,000/mcL or ≤ 100,000,000/mcL
AST (SGOT) ≤ 2.5 times the institutional upper limit of normal
ALT (SGPT) ≤ 2.5 times the institutional upper limit of normal
Total bilirubin within the upper limit of institutional normal range
Serum Creatinine within the upper limit of institutional normal range

Exclusion Criteria

Radiographic evidence of bowel obstruction
Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after enrollment
Isolated small bowel or ostomy surgery without colon or rectal resection
ASA score 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
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)
History of allergic reactions attributed to PYR or other acetylcholine esterase inhibitors
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cleveland?

Yes, this clinical trial (NCT05334485) has an active research site in Cleveland, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Postoperative Ileus Treatment Options in Cleveland, OH

If you're searching for postoperative ileus treatment options in Cleveland, OH, this clinical trial (NCT05334485) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cleveland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced postoperative ileus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all postoperative ileus clinical trials near you to find additional studies recruiting in your area.

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