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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by University of Nebraska.
Recruitment status was:  Enrolling by invitation
Information provided by:
University of Nebraska Identifier:
First received: June 30, 2010
Last updated: August 2, 2011
Last verified: August 2011
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.

Condition Intervention Phase
Drug: stool softener
Device: Arm B: Acupressure bracelet
Dietary Supplement: sugar free gum
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Timing of first post operative bowel movement [ Time Frame: Days post operative ]
    First bowel movement

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Time from admission to discharge post surgery ]
    Length of stay

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm A: Standard therapy (use of medications)
Drug: stool softener
ducosate sodium, Milk of Magnesia, dulcolax
Experimental: Arm B: Acupressure bracelets
device - Biobands
Device: Arm B: Acupressure bracelet
Other Name: Bioband
Experimental: Arm C
Sugar free gum
Device: Arm B: Acupressure bracelet
Other Name: Bioband
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.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01156129

United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3285
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Laurel Williams, MSN,RN University of Nebraska
  More Information

Responsible Party: Laurel Williams Salonen, RN, MSN, CCTC Transplant & Research Coordinator, University of Nebraska Medical Center Identifier: NCT01156129     History of Changes
Other Study ID Numbers: 228-10
Study First Received: June 30, 2010
Last Updated: August 2, 2011

Keywords provided by University of Nebraska:
liver transplant
liver resection

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bismuth subsalicylate
Gastrointestinal Agents processed this record on April 28, 2017