Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01956643
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 6.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Other: gum chewing; Other: Control	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. time to flatus [an expected average of 75 hours]

Secondary Outcome Measures

1. percentage of target calories [an average 4 days]

2. ICU length of stay [an average 96 hous]

3. hospital length of stay [an average 20 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ho Geol Ryu, Assistant Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01956643
• Other Study ID Numbers: ShamLT
• First Posted: Oct 8, 2013
• Last Update Posted: Sep 25, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Ho Geol Ryu, Assistant Professor, Seoul National University Hospital: sham feeding; postoperative ileus; liver transplantation
• Additional relevant MeSH terms: Ileus

Study Results

No Results Posted as of Sep 25, 2019