NCT05334485

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery (PESTI Trial)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Stefan Holubar MD MS FACS, FASCRS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Postoperative Ileus

Interventions

Type	Name	Description
DRUG	Pyridostigmine Bromide	Oral 60mg pyridostigmine bromide
OTHER	Placebo	Oral starch placebo

Timeline

• Start date: 2024-09-03
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2022-04-19
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study