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Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

Primary Purpose

Postoperative Ileus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gum chewing
Control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring sham feeding, postoperative ileus, liver transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

gum chewing

Control

Arm Description

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.

Routine care during NPO

Outcomes

Primary Outcome Measures

time to flatus

Secondary Outcome Measures

percentage of target calories
ICU length of stay
hospital length of stay

Full Information

First Posted
September 27, 2013
Last Updated
September 23, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01956643
Brief Title
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
Official Title
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
sham feeding, postoperative ileus, liver transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gum chewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Routine care during NPO
Intervention Type
Other
Intervention Name(s)
gum chewing
Intervention Description
gum chewing
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Routine care during NPO
Primary Outcome Measure Information:
Title
time to flatus
Time Frame
an expected average of 75 hours
Secondary Outcome Measure Information:
Title
percentage of target calories
Time Frame
an average 4 days
Title
ICU length of stay
Time Frame
an average 96 hous
Title
hospital length of stay
Time Frame
an average 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hogeol Ryu, MD. PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

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