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

Phase 1

Completed

• Conditions: Ileus
• Interventions: Drug: stool softener; Dietary Supplement: sugar free gum

• Registration Number: NCT01156129
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Study Start: 2010-09-01
• Primary Completion: 2012-07-01
• Study Completion: 2012-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-02
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A: Standard therapy (use of medications)	stool softener	stool softener
Arm C	sugar free gum	Sugar free gum

Primary Outcome Measures

Name	Time	Method
Timing of first post operative bowel movement	Days post operative	First bowel movement

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Time from admission to discharge post surgery	Length of stay

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States