RecruitingPhase 2Phase 3NCT05334485

Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

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

Sponsor

Stefan Holubar MD MS FACS, FASCRS

Enrollment

50 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Postoperative Ileus

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether pyridostigmine — a medication that stimulates intestinal muscle contractions — can safely and effectively treat postoperative ileus (POI), a condition where the bowel temporarily stops working after surgery, causing bloating, nausea, and inability to pass gas or stool. POI is a common complication after colorectal surgery that prolongs hospital stays, and there is currently no approved rescue therapy. Adults aged 18 and older who have undergone elective colorectal surgery and develop confirmed POI (with no bowel activity for at least 48 hours after initial diet attempts) with imaging confirmation are eligible. Participation involves being randomly assigned to receive pyridostigmine or a placebo alongside standard care, with side effects tracked using a structured scale after each dose. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.