Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

NCT ID: NCT01956643

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

gum chewing

Intervention Type OTHER

gum chewing

Control

Routine care during NPO

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Routine care during NPO

Interventions

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gum chewing

gum chewing

Intervention Type OTHER

Control

Routine care during NPO

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ho Geol Ryu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hogeol Ryu, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ShamLT

Identifier Type: -

Identifier Source: org_study_id

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