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

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

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.

Study Overview

• Status: Completed
• Conditions: Ileus
• Intervention / Treatment: Drug: stool softener; Device: Arm B: Acupressure bracelet; Dietary supplement: sugar free gum

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Unversity of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Laurel W Williams, MSN,RN, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimated): July 2, 2010

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: liver transplant; liver resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Gastrointestinal Agents; Cathartics; Laxatives; Antidiarrheals; Bisacodyl; Bismuth subsalicylate
• Other Study ID Numbers: 0228-10-FB