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

NCT ID: NCT01156129

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-01
• Study Completion Date: 2012-12-01

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.

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.

Conditions

Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A: Standard therapy (use of medications)

stool softener

Group Type: ACTIVE_COMPARATOR

stool softener

Intervention Type: DRUG

ducosate sodium, Milk of Magnesia, dulcolax

Arm B: Acupressure bracelets

device - Biobands

Group Type: EXPERIMENTAL

Arm B: Acupressure bracelet

Intervention Type: DEVICE

Bioband

Arm C

Sugar free gum

Group Type: EXPERIMENTAL

sugar free gum

Intervention Type: DIETARY_SUPPLEMENT

Orbit

Interventions

stool softener

ducosate sodium, Milk of Magnesia, dulcolax

Intervention Type: DRUG

Arm B: Acupressure bracelet

Bioband

Intervention Type: DEVICE

sugar free gum

Orbit

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Milk of Magnesia, Dulcolax; Bioband; generic

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurel W Williams, MSN,RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0228-10-FB

Identifier Type: -

Identifier Source: org_study_id