Postoperative IleusNCT01956643
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
A study testing gum chewing in people with Postoperative Ileus, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- gum chewing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective liver transplantation surgery
- an ability to chew gum
Who cannot join
- emergency surgery
- age less than 18 years,
- inability to provide written informed consent
- an inability to chew gum
- hepaticojejunostomy
- sedated patients
Show all 10Show fewer
- reintubated patients
- Glasgow Coma Scale <13
- reoperation before gas out
- previous bowel surgery
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery.
The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.
- Conditions
- Postoperative Ileus
- Being tested
- gum chewing, Control
- Keywords
- sham feeding, postoperative ileus, liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gum chewingOther
gum chewing
ControlOther
Routine care during NPO
| Study group | Role | What they receive |
|---|---|---|
| gum chewing | Experimental | Gum type was standardized with all subjects receiving sugar-free xylitol gum.
The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (two tablets) 3 times daily in the morning, afternoon, and evening for 15 min. The administration of the therapy was implemented by ICU nurses and recorded in the clinical report form file. All gum-chewing patients completed their course of gum chewing until gas out. Receives: Other: gum chewing |
| Control | Placebo comparator | Routine care during NPO Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to flatus
Measured: an expected average of 75 hours
Secondary outcomes (3)
percentage of target calories
Measured: an average 4 days
ICU length of stay
Measured: an average 96 hous
hospital length of stay
Measured: an average 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Geol Ryu, Seoul National University Hospital
- Investigators
- Hogeol Ryu, MD. PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956643
- Sponsor's protocol ID
- ShamLT
- Status last verified
- Sep 2019
- First submitted
- 27 Sep 2013
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
- ClinicalTrials.gov ID
- NCT01956643
- Acronym / sponsor ID
- ShamLT
- Conditions
- Postoperative Ileus
- Keywords
- sham feeding, postoperative ileus, liver transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 8 Oct 2013 (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.
Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery.
The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gum chewing | Experimental | Other: gum chewingGum type was standardized with all subjects receiving sugar-free xylitol gum. The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (two tablets) 3 times daily in the morning, afternoon, and evening for 15 min. The administration of the therapy was implemented by ICU nurses and recorded in the clinical report form file. All gum-chewing patients completed their course of gum chewing until gas out. |
| Control | Placebo comparator | Other: ControlRoutine care during NPO |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective liver transplantation surgery
- an ability to chew gum
Key exclusion criteria (10 listed)
- emergency surgery
- age less than 18 years,
- inability to provide written informed consent
- an inability to chew gum
- hepaticojejunostomy
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 |
|---|---|---|
| gum chewinggum chewing | Other | gum chewing |
| ControlRoutine care during NPO | Other | Control |
Primary outcome
time to flatus
Time frame: an expected average of 75 hours
3 secondary outcomes
percentage of target calories
Time frame: an average 4 days
ICU length of stay
Time frame: an average 96 hous
hospital length of stay
Time frame: an average 20 days
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 25 Sep 2019.
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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.
Hogeol Ryu, MD. PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gum chewing in people with Postoperative Ileus, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 10 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 25 Sep 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
time to flatus (time frame: an expected average of 75 hours). 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 25 Sep 2019.