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CompletedNCT01156129Updated Sep 7, 2023

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

A Phase 1 interventional study of stool softener and Arm B: Acupressure bracelet in Ileus, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by University of Nebraska · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ileus

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Keywords

  • liver transplant
  • liver resection
03

In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's enrollment of 111 is above the median of 90 across 138 interventional studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery

Exclusion criteria

Exclusion Criteria:

  • Patients less than 19 years of age having liver transplant or liver resection surgery
  • Non-English speaking
  • Pregnancy
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
111 participants (actual)

Study arms

  • Active comparator
    Arm A: Standard therapy (use of medications)

    stool softener

    Drug: stool softener

  • Experimental
    Arm B: Acupressure bracelets

    device - Biobands

    Device: Arm B: Acupressure bracelet

  • Experimental
    Arm C

    Sugar free gum

    Dietary Supplement: sugar free gum

Interventions

  • Drugstool softener

    ducosate sodium, Milk of Magnesia, dulcolax

    Also known as: Milk of Magnesia, Dulcolax

  • DeviceArm B: Acupressure bracelet

    Bioband

    Also known as: Bioband

  • Dietary supplementsugar free gum

    Orbit

    Also known as: generic

06

What researchers measure

Primary outcomes

  1. Timing of first post operative bowel movement

    First bowel movement

    Time frame: Days post operative

Secondary outcomes

  1. Length of hospital stay

    Length of stay

    Time frame: Time from admission to discharge post surgery

07

Study locations

1 site
  • Unversity of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01156129
Responsible party
Sponsor
First posted
Jul 2, 2010
Start date
Sep 1, 2010
Primary completion
Jul 1, 2012
Completion
Dec 1, 2012
Last update
Sep 7, 2023

Study contacts

Laurel W Williams, MSN,RN
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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