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Completed

NCT Number: NCT01156129

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.

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Key information

Conditions

Ileus Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Obstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stool softener

Drug

ducosate sodium, Milk of Magnesia, dulcolax

Other names: Milk of Magnesia, Dulcolax

Arm B: Acupressure bracelet

Device

Bioband

Other names: Bioband

sugar free gum

Dietary Supplement

Orbit

Other names: generic

Primary outcomes

  1. Timing of first post operative bowel movement

    Time frame: Days post operative

    First bowel movement

Secondary outcomes

  1. Length of hospital stay

    Time frame: Time from admission to discharge post surgery

    Length of stay

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 2, 2010
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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