IleusPhase 1NCT01156129
Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery
A Phase 1 study testing stool softener, Arm B: Acupressure bracelet and sugar free gum in people with Ileus, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ileus
- What is being tested?
- stool softener, Arm B: Acupressure bracelet and sugar free gum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 1 Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery
Who cannot join
- Patients less than 19 years of age having liver transplant or liver resection surgery
- Non-English speaking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery
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.
Read the 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
- Being tested
- stool softener, Arm B: Acupressure bracelet, sugar free gum
- Keywords
- liver transplant, liver resection
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool softenerDrug
Also called Milk of Magnesia, Dulcolax
ducosate sodium, Milk of Magnesia, dulcolax
Arm B: Acupressure braceletDevice
Also called Bioband
Bioband
sugar free gumDietary supplement
Also called generic
Orbit
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard therapy (use of medications) | Active comparator | stool softener Receives: Drug: stool softener |
| Arm B: Acupressure bracelets | Experimental | device - Biobands Receives: Device: Arm B: Acupressure bracelet |
| Arm C | Experimental | Sugar free gum Receives: Dietary Supplement: sugar free gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of first post operative bowel movement
First bowel movement
Measured: Days post operative
Secondary outcomes (1)
Length of hospital stay
Length of stay
Measured: Time from admission to discharge post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study start1 Sep 2010
- Primary completion1 Jul 2012
- Study completion1 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurel W Williams, MSN,RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156129
- Sponsor's protocol ID
- 0228-10-FB
- Status last verified
- Sep 2023
- First submitted
- 30 Jun 2010
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Decrease the Impact of Post-Operative Ileus After Liver Transplant or Resection Surgery
- ClinicalTrials.gov ID
- NCT01156129
- Acronym / sponsor ID
- 0228-10-FB
- Conditions
- Ileus
- Keywords
- liver transplant, liver resection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Dec 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard therapy (use of medications) | Active comparator | Drug: stool softenerstool softener |
| Arm B: Acupressure bracelets | Experimental | Device: Arm B: Acupressure braceletdevice - Biobands |
| Arm C | Experimental | Dietary Supplement: sugar free gumSugar free gum |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery
Key exclusion criteria (3 listed)
- Patients less than 19 years of age having liver transplant or liver resection surgery
- Non-English speaking
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool softenerAlso: Milk of Magnesia, Dulcolaxducosate sodium, Milk of Magnesia, dulcolax | Drug | Arm A: Standard therapy (use of medications) |
| Arm B: Acupressure braceletAlso: BiobandBioband | Device | Arm B: Acupressure bracelets |
| sugar free gumAlso: genericOrbit | Dietary supplement | Arm C |
Primary outcome
Timing of first post operative bowel movement
Time frame: Days post operative
First bowel movement
1 secondary outcome
Length of hospital stay
Time frame: Time from admission to discharge post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
Related trials for Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingObservational study
The Effect of Ostomy Care Education Applied With the Teach-Back Method to Ostomy-Opened Individuals on Self-Care Power, Ostomy Adjustment, and Anxiety
Ostomy - Ileostomy or Colostomy, Canser
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurel W Williams, MSN,RN principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stool softener, Arm B: Acupressure bracelet and sugar free gum in people with Ileus, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of first post operative bowel movement (time frame: Days post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.