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

NCT01156129 | Completed Phase 1

• 1 other identifier: 0228-10-FB
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ileus

Keywords

liver transplant; liver resection

Outcome Measures

Primary Outcomes (1)

• Timing of first post operative bowel movement

  First bowel movement

  Days post operative

Secondary Outcomes (1)

• Length of hospital stay

  Time from admission to discharge post surgery

Study Arms (3)

Arm A: Standard therapy (use of medications)

ACTIVE COMPARATOR

stool softener

Drug: stool softener

Arm B: Acupressure bracelets

EXPERIMENTAL

device - Biobands

Device: Arm B: Acupressure bracelet

Arm C

EXPERIMENTAL

Sugar free gum

Dietary Supplement: sugar free gum

Interventions

stool softener DRUG

ducosate sodium, Milk of Magnesia, dulcolax

Also known as: Milk of Magnesia, Dulcolax

Arm A: Standard therapy (use of medications)

Arm B: Acupressure bracelet DEVICE

Bioband

Also known as: Bioband

Arm B: Acupressure bracelets

sugar free gum DIETARY_SUPPLEMENT

Orbit

Also known as: generic

Arm C

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Ileus

Interventions

Dioctyl Sulfosuccinic Acid; Magnesium Hydroxide; Bisacodyl; Drugs, Generic

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Magnesium Compounds; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pharmaceutical Preparations

Study Officials

• Laurel W Williams, MSN,RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 2, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)