WithdrawnNot Applicable

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

Stopped: Investigator decision - clinical practice change

United States0Started 2017-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean time to GI function recovery (GI-3)

Timeframe: An expected average of 5 days

Trial details

NCT IDNCT02250924

SponsorThe Guthrie Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05

View on ClinicalTrials.gov More C.Surgical Procedure; Digestive System trials