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Clinical Trials/NCT02250924
NCT02250924WithdrawnNot Applicable

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

The Guthrie Clinic2 sites in 1 countryStarted: January 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
2
Primary Endpoint
Mean time to GI function recovery (GI-3)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mean time to GI function recovery (GI-3)

Time Frame: An expected average of 5 days

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Caffeinated Gum to Prevent Post-Operative... | Clinical Trial