Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

September 23, 2019 updated by: Ho Geol Ryu, Seoul National University Hospital

Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery.

The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective liver transplantation surgery
  • an ability to chew gum

Exclusion Criteria:

  • emergency surgery
  • age less than 18 years,
  • inability to provide written informed consent
  • an inability to chew gum
  • hepaticojejunostomy
  • sedated patients
  • reintubated patients
  • Glasgow Coma Scale <13
  • reoperation before gas out
  • previous bowel surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: gum chewing

Gum type was standardized with all subjects receiving sugar-free xylitol gum.

The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (two tablets) 3 times daily in the morning, afternoon, and evening for 15 min. The administration of the therapy was implemented by ICU nurses and recorded in the clinical report form file. All gum-chewing patients completed their course of gum chewing until gas out.
Other: gum chewing
gum chewing
PLACEBO_COMPARATOR: Control
Routine care during NPO
Other: Control
Routine care during NPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to flatus
Time Frame: an expected average of 75 hours
an expected average of 75 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of target calories
Time Frame: an average 4 days
an average 4 days
ICU length of stay
Time Frame: an average 96 hous
an average 96 hous
hospital length of stay
Time Frame: an average 20 days
an average 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hogeol Ryu, MD. PhD., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShamLT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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