Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Stefan Holubar MD MS FACS, FASCRS
Study ID
NCT05334485
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Postoperative Ileus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pyridostigmine Bromide — DRUG
    Oral 60mg pyridostigmine bromide
  • Placebo — OTHER
    Oral starch placebo

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pyridostigmine
    Patients randomized to this group will be given 60mg of pyridostigmine bromide orally, every 12 hours. Pyridostigmine will be administered from the time of diagnosis of postoperative ileus until the return of bowel function, or for a maximum of 48 hours.
  • Placebo Comparator: Placebo
    Patients randomized to this group will be given starch orally, every 12 hours for a maximum of 48 hours.

Primary Outcome Measure

Time until return of bowel function [ Time Frame: Time from administration of pyridostigmine bromide or placebo until first passage of flatus for up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Main CampusClevelandOhio44195
Stefan D Holubar, MD/MS
[email protected]
2164447000

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Main Campus· Cleveland, OH

Related Studies