Clinical trial

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

Name

0228-10-FB

Description

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.

Trial arms

Trial start

2010-09-01

Estimated PCD

2012-07-01

Trial end

2012-12-01

Status

Completed

Phase

Early phase I

Treatment

stool softener

ducosate sodium, Milk of Magnesia, dulcolax

Arms:

Arm A: Standard therapy (use of medications)

Other names:

Milk of Magnesia, Dulcolax

Arm B: Acupressure bracelet

Bioband

Arms:

Arm B: Acupressure bracelets

Other names:

Bioband

sugar free gum

Orbit

Arms:

Arm C

Other names:

generic

Size

111

Primary endpoint

Timing of first post operative bowel movement

Days post operative

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 111, 'type': 'ACTUAL'}}

Updated at

2023-09-07

1 organization

1 product

1 indication

Organization

University of Nebraska

Product

Stool Softener

Indication

Ileus