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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01156129
First received: June 30, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    First bowel movement


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Time from admission to discharge post surgery ] [ Designated as safety issue: No ]
    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
Drug: stool softener
ducosate sodium, Milk of Magnesia, dulcolax
Experimental: Arm B: Acupressure bracelets
device - Biobands
Device: Arm B: Acupressure bracelet
Bioband
Other Name: Bioband
Experimental: Arm C
Sugar free gum
Device: Arm B: Acupressure bracelet
Bioband
Other Name: Bioband
Dietary Supplement: sugar free gum
Orbit

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01156129

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

No publications provided

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

Keywords provided by University of Nebraska:
liver transplant
liver resection

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bismuth subsalicylate
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014