Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Launched by STEFAN HOLUBAR MD MS FACS, FASCRS · Apr 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pyridostigmine to see if it can help patients who develop postoperative ileus (a condition where the intestines don’t work properly) after colorectal surgery. The trial is open to adults aged 18 and older who have had colorectal surgery and are experiencing symptoms like bloating, nausea, or not being able to pass gas or stool for at least 48 hours. Participants will be randomly assigned to receive either pyridostigmine or a placebo (a dummy treatment) in addition to standard care, and their safety will be monitored throughout the study.

If you or a loved one are eligible, you can expect to complete some questionnaires about side effects during the trial. It’s important to know that certain health conditions and medications may prevent someone from participating, so eligibility will be carefully assessed. This trial aims to improve treatment options for postoperative ileus, potentially leading to better recovery experiences for patients after surgery.

Gender

ALL

Eligibility criteria

• 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
• • 7. Serum Creatinine within the upper limit of institutional normal range
• 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