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

University of Nebraska

Status and phase: Completed; Phase 1

Conditions: Ileus

Treatments: Device: Arm B: Acupressure bracelet; Drug: stool softener; Dietary Supplement: sugar free gum

Study type: Interventional

Funder types: Other

Identifiers

NCT01156129

0228-10-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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111 participants in 3 patient groups

Arm A: Standard therapy (use of medications)

Active Comparator group

Description:

stool softener

Treatment:

Drug: stool softener

Arm B: Acupressure bracelets

Experimental group

Description:

device - Biobands

Treatment:

Device: Arm B: Acupressure bracelet

Arm C

Experimental group

Description:

Sugar free gum

Treatment:

Dietary Supplement: sugar free gum