Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Recruiting Phase 2 Phase 3 Interventional Study
Postoperative Ileus
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Stefan Holubar MD MS FACS, FASCRS · Other
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About This Trial
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 …
Trial Locations
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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 bloat…
Contacts

Stefan D Holubar

2164447000

holubas@ccf.org

CONTACT