Actively Recruiting
Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery (PESTI Trial)
Led by Stefan Holubar MD MS FACS, FASCRS · Updated on 2026-01-07
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of pyridostigmine as a rescue treatment for postoperative ileus in patients who have undergone elective colorectal surgery. This randomized, double-blind, placebo-controlled trial involves adults with benign or malignant colonic or rectal disease who develop postoperative ileus, characterized by symptoms like bloating and absence of bowel movements for at least 48 hours after surgery. The study aims to compare pyridostigmine with placebo alongside standard care to better understand its impact on bowel function recovery. Participants will be randomly assigned to one of two groups: one receiving 60 mg of oral pyridostigmine bromide every 12 hours, and the other receiving an oral starch placebo every 12 hours. Treatment will continue from the time postoperative ileus is diagnosed until the return of bowel function or for a maximum of 48 hours. Side effects will be monitored using a specific side effects scale completed at enrollment and after each dose. During the study, participants will be closely monitored for the time until the first passage of gas and stool, tolerance of solid food, and any complications or need for re-operation or hospital readmission within 30 days after surgery. Safety assessments include surveys for side effects after each dose. The total participation period includes follow-up for up to 30 days to capture important recovery and complication outcomes related to postoperative ileus treatment.
CONDITIONS
Brief Title
Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older with benign or malignant colonic or rectal disease
- Underwent elective laparoscopic, robotic, or open colorectal resection with or without ostomy
- Developed postoperative ileus defined by bloating with or without nausea/vomiting, no passage of flatus or stool for at least 48 hours, requiring return to NPO after initial diet attempts
- Radiographic confirmation of postoperative ileus by abdominal X-ray or CT scan
- ECOG performance status less than 4
- Normal organ function based on lab tests including hemoglobin, white blood cell count, platelet count, liver enzymes, bilirubin, and creatinine
You will not qualify if you...
- Evidence of bowel obstruction on imaging
- Intraabdominal septic complications such as abscess, peritonitis, or anastomotic leak
- Surgery involving only small bowel or ostomy without colon or rectal resection
- ASA score of 5
- Pregnant or breastfeeding females
- Current use of other investigational agents or medications affecting bowel motility
- History of allergy to pyridostigmine or similar drugs
- Uncontrolled illnesses including myasthenia gravis, asthma, COPD, heart failure, unstable angina, arrhythmia, renal or hepatic failure, gastroparesis, short bowel syndrome, bowel dysmotility, chronic constipation, peritoneal carcinomatosis, or psychiatric/social conditions limiting compliance
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 hours
Participants receive oral doses of pyridostigmine bromide or placebo every 12 hours from diagnosis of postoperative ileus until return of bowel function or for a maximum of 48 hours.
Multiple administrations every 12 hours
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Stefan D Holubar
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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