Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
Primary Purpose
Ileus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stool softener
Arm B: Acupressure bracelet
sugar free gum
Sponsored by
About this trial
This is an interventional treatment trial for Ileus focused on measuring liver transplant, liver resection
Eligibility Criteria
Inclusion Criteria:
- Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery
Exclusion Criteria:
- Patients less than 19 years of age having liver transplant or liver resection surgery
- Non-English speaking
- Pregnancy
Sites / Locations
- Unversity of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm A: Standard therapy (use of medications)
Arm B: Acupressure bracelets
Arm C
Arm Description
stool softener
device - Biobands
Sugar free gum
Outcomes
Primary Outcome Measures
Timing of first post operative bowel movement
First bowel movement
Secondary Outcome Measures
Length of hospital stay
Length of stay
Full Information
NCT ID
NCT01156129
First Posted
June 30, 2010
Last Updated
September 2, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT01156129
Brief Title
Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
Official Title
Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
July 1, 2012 (Actual)
Study Completion Date
December 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in adult patients on the liver transplant service undergoing either liver transplant or resection surgery. Patient who speak and understand English will be randomized into one of three groups including a.)control group receiving standard therapy for post-operative ileus, b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving standard therapy and sugar free gum four times daily.
Detailed Description
Any patient undergoing liver transplant or resection surgery will be asked to participate in the study and assigned to a control or investigational group. Pertinent information will be collected from the medical record including gender, age in years, diagnosis, type of surgery, length of stay, medications used for pain or nausea, and first bowel movement. The subjects will also be asked to keep a journal of their bowel habits, signs and symptoms of gastrointestinal distress/post-operative ileus, use of medications, first bowel movement, satisfaction with bowel management and any additional comments.
Aims of the study are to determine the effectiveness of the three arms of this trial for the resolution of POI as noted by first post-operative bowel movement; to determine if there is a difference in the length of stay based on the interventions; and to determine if there is a difference in patient satisfaction based on the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
liver transplant, liver resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Standard therapy (use of medications)
Arm Type
Active Comparator
Arm Description
stool softener
Arm Title
Arm B: Acupressure bracelets
Arm Type
Experimental
Arm Description
device - Biobands
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Sugar free gum
Intervention Type
Drug
Intervention Name(s)
stool softener
Other Intervention Name(s)
Milk of Magnesia, Dulcolax
Intervention Description
ducosate sodium, Milk of Magnesia, dulcolax
Intervention Type
Device
Intervention Name(s)
Arm B: Acupressure bracelet
Other Intervention Name(s)
Bioband
Intervention Description
Bioband
Intervention Type
Dietary Supplement
Intervention Name(s)
sugar free gum
Other Intervention Name(s)
generic
Intervention Description
Orbit
Primary Outcome Measure Information:
Title
Timing of first post operative bowel movement
Description
First bowel movement
Time Frame
Days post operative
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of stay
Time Frame
Time from admission to discharge post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery
Exclusion Criteria:
Patients less than 19 years of age having liver transplant or liver resection surgery
Non-English speaking
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurel W Williams, MSN,RN
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
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