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.
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
Hemoglobin ≥ 7.0 g/dL
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
Parallel
Pyridostigmine Bromide
DrugOral 60mg pyridostigmine bromide
Placebo
Other interventionOral starch placebo
Time until return of bowel function
Following the administration of either pyridostigmine bromide or placebo, the time (in minutes) until return of bowel function will be recorded. Return of bowel function is defined as the first passage of flatus.
Incidence of pyridostigmine bromide associated side effects
Side effects of pyridostigmine bromide will be assessed using the Pyridostigmine Bromide Side Effects Scale (PBSES) survey tool. Participants will complete this survey at specific time points to evaluate and monitor for the development of established side effects associated with pyridostigmine bromide administration.
Time to passage of stool after postoperative ileus diagnosis
The amount of time (in minutes) from the participant being diagnosed with postoperative ileus confirmed with imaging findings until the first passage of stool.
Time to tolerance of solid food after postoperative ileus
The amount of time (in minutes) from the participant being diagnosed with postoperative ileus confirmed with imaging findings until the first tolerance of solid food.
Number of participants with complications
The number of participants with any type of complication or adverse event occurring within the first 30-days following surgery.
Number of participants requiring re-operation
The number of participants who require a re-operation for any reason during the first 30-days following the initial operation.
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Stefan Holubar MD MS FACS, FASCRS
Lead sponsor
The Cleveland Clinic
Sponsor institution
