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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Oral 60mg pyridostigmine bromide
Oral starch placebo
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
RECRUITINGTime 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.
Time frame: Time from administration of pyridostigmine bromide or placebo until first passage of flatus for up to 30 days
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 frame: Participants will complete the survey at enrollment and then again at 30 minutes following each administration of either pyridostigmine bromide or placebo.
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 frame: Time from the point of postoperative ileus diagnosis until the first passage of stool for up to 30 days
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.
Time frame: Time from the point of postoperative ileus diagnosis until first meal in which solid food is tolerated for up to 30 days
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.
Time frame: 30-day period 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.
Time frame: 30-day period following initial surgery
Number of participants requiring re-admission
The number of participants requiring re-admission to the hospital for any reason during the first 30-days following surgery.
Time frame: 30-day period following surgery
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