Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery

Conditions
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Ileus

Intervention / Treatment
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* Drug: stool softener
* Device: Arm B: Acupressure bracelet
* Dietary Supplement: sugar free gum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Standard therapy (use of medications)<br>stool softener | Drug: stool softener<br>* ducosate sodium, Milk of Magnesia, dulcolax<br>* Other names: Milk of Magnesia, Dulcolax;|
| Experimental: Arm B: Acupressure bracelets<br>device - Biobands | Device: Arm B: Acupressure bracelet<br>* Bioband<br>* Other names: Bioband;|
| Experimental: Arm C<br>Sugar free gum | Dietary Supplement: sugar free gum<br>* Orbit<br>* Other names: generic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of first post operative bowel movement | First bowel movement | Days post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of stay | Time from admission to discharge post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplant, liver resection