Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedSeptember 25, 2019
September 1, 2019
11 months
September 27, 2013
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to flatus
an expected average of 75 hours
Secondary Outcomes (3)
percentage of target calories
an average 4 days
ICU length of stay
an average 96 hous
hospital length of stay
an average 20 days
Study Arms (2)
gum chewing
EXPERIMENTALGum 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.
Control
PLACEBO COMPARATORRoutine care during NPO
Interventions
Eligibility Criteria
You may qualify if:
- elective liver transplantation surgery
- an ability to chew gum
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hogeol Ryu, MD. PhD.
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 27, 2013
First Posted
October 8, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
September 25, 2019
Record last verified: 2019-09