RecruitingPhase 2ACTRN12620001262998

Pyridostigmine to reduce the duration of postoperative Ileus in patients undergoing colorectal surgery

PyRICo-P – Pyridostigmine to Reduce the duration of postoperative Ileus after Colorectal Surgery – a Phase II study.


Sponsor

The Royal Adelaide Hospital

Enrollment

15 participants

Start Date

Sep 17, 2020

Study Type

Interventional

Conditions

Summary

Post-operative ileus (POI) is characterized by impairment of bowel motility and is a common complication after major abdominal surgery in general, and after colorectal surgery in particular. The principal features of POI include nausea and vomiting, inability to tolerate diet, significant abdominal distension and delayed passage of flatus and stool. POI as a complication has the largest overall effect on length of postoperative hospitalization. The purpose of this phase II trial is to determine the safety and effectiveness of oral pyridostigmine after elective colorectal surgery. We hypothesise that, within an optimised Enhanced Recovery Protocols (ERPs) setting, giving oral pyridostigmine to patients post-operatively will result in a reduction in the duration of postoperative Ileus.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase 2 trial tests whether a medication called pyridostigmine — originally used to treat a nerve-muscle condition called myasthenia gravis — can help restore bowel function faster after colorectal surgery. After operations on the bowel (such as removal of part of the colon), the gut often 'goes to sleep' for several days, causing nausea, bloating, and an inability to eat — a condition called postoperative ileus. This is one of the main reasons patients stay in hospital longer than expected. Pyridostigmine works by boosting the signals from nerves to the gut, potentially waking the bowel up sooner. Participants are randomly assigned to receive oral pyridostigmine or a placebo after their bowel surgery, and researchers track how quickly normal gut function returns. The trial is run within a modern enhanced recovery protocol, which already optimises many aspects of post-surgical care. You may be eligible if you are 18 or older, are undergoing planned colorectal surgery at the Royal Adelaide Hospital, and can give informed consent. People with certain heart conditions, asthma requiring regular medication, epilepsy, Parkinson's disease, peptic ulcers, significant kidney impairment, or active inflammatory bowel disease are not eligible.

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.

Interventions

Study participants will receive standard peri-operative care as per our current Enhanced recovery protocol (ERP) but with the addition of Name: Pyridostigmine bromide Dose: 60 mg twice a day

Study participants will receive standard peri-operative care as per our current Enhanced recovery protocol (ERP) but with the addition of Name: Pyridostigmine bromide Dose: 60 mg twice a day Duration: From the day of surgery, six hours after the operation until the passage of stool Mode of administration: Oral tablet Adherence to the intervention would be monitored by routine checking of medication administration charts


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12620001262998


Related Trials