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

Not Applicable

Withdrawn

• Conditions: C.Surgical Procedure; Digestive System
• Interventions: Other: Gum; Behavioral: wear silicone bracelet; Dietary Supplement: Caffeine

• 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

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Study Start: 2017-01
• Primary Completion: 2020-05
• Study Completion: 2020-05-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-04

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Sugar-less Gum	Gum	Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Placebo	wear silicone bracelet	Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Caffeinated Gum	Caffeine	Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Caffeinated Gum	Gum	Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

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

Trial Locations

Locations (1)

The Guthrie Clinic; 🇺🇸 Sayre, Pennsylvania, United States