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

Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156129
• Other study ID #: 0228-10-FB
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2010
• Est. completion date: December 1, 2012

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 1, 2012
• Est. primary completion date: July 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus

Intervention

Drug:
• stool softener
ducosate sodium, Milk of Magnesia, dulcolax

Device:
• Arm B: Acupressure bracelet
Bioband

Dietary Supplement:
• sugar free gum
Orbit

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timing of first post operative bowel movement	First bowel movement	Days post operative
Secondary	Length of hospital stay	Length of stay	Time from admission to discharge post surgery