Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
Not Applicable
Withdrawn
- Conditions
- C.Surgical Procedure; Digestive System
- Registration Number
- NCT02250924
- Lead Sponsor
- The Guthrie Clinic
- Brief Summary
This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.
Exclusion Criteria
- ASA physical status score of >3, GCS < 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean time to GI function recovery (GI-3) An expected average of 5 days
- Secondary Outcome Measures
Name Time Method Mean length of postoperative hospitalization Up to 30 days Rate of postoperative ileus Up to 30 days Adverse event rates Up to 30 days postoperative
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does caffeine target to prevent post-operative ileus in abdominal surgery patients?
How does caffeinated gum compare to standard-of-care treatments for post-operative ileus in terms of effectiveness and recovery time?
Are there specific biomarkers that can predict which patients will respond best to caffeinated gum for post-operative ileus prevention?
What are the potential adverse events associated with caffeine use in post-operative recovery and how can they be managed?
What other compounds or combination therapies have shown promise in preventing post-operative ileus alongside caffeine?
Trial Locations
- Locations (1)
The Guthrie Clinic
🇺🇸Sayre, Pennsylvania, United States
The Guthrie Clinic🇺🇸Sayre, Pennsylvania, United States