Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

C.Surgical Procedure; Digestive System Clinical Trial

Official title:

Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02250924
• Other study ID #: GC1410-55
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 28, 2020

Study information

• Verified date: June 2020
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 28, 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C.Surgical Procedure; Digestive System

Intervention

Dietary Supplement:
• Caffeine
caffeinated gum

Other:
• Gum
Chewing gum

Behavioral:
• wear silicone bracelet
Subjects will put on bracelet to correspond with times for chewing gum

Locations

Country	Name	City	State
United States	The Guthrie Clinic	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time to GI function recovery (GI-3)		An expected average of 5 days
Secondary	Mean length of postoperative hospitalization		Up to 30 days
Secondary	Rate of postoperative ileus		Up to 30 days
Secondary	Adverse event rates		Up to 30 days postoperative