Post-operative IleusNCT01869231
Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus
A study testing olive oil, olive oil and chewing gum and chewing gum in people with Post-operative Ileus, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial summary
Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-operative Ileus
- What is being tested?
- olive oil, olive oil and chewing gum and chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Dec 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients underwent abdominal surgery for non neoplastic diseases
Who cannot join
- Metastatic disease
- History of inflammatory bowel disease
- Postoperative fever
- Gastrointestinal fistula
- Mint or olive allergy; and/or
- Earlier abdominal radiation
Trial locations and contacts
1 site in 1 country.
About this study
Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.
- Conditions
- Post-operative Ileus
- Being tested
- olive oil, olive oil and chewing gum, chewing gum, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olive oilDietary supplement
olive oil and chewing gumDietary supplement
chewing gumDietary supplement
waterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| major surgery | Experimental | colic surgery Receives: Dietary Supplement: olive oil; Dietary Supplement: olive oil and chewing gum; Dietary Supplement: chewing gum; Dietary Supplement: water |
| minor surgery | Experimental | appendectomy; cholecystectomy Receives: Dietary Supplement: olive oil; Dietary Supplement: olive oil and chewing gum; Dietary Supplement: chewing gum; Dietary Supplement: water |
| ileostomy and colostomy | Experimental | ileostomy colostomy Receives: Dietary Supplement: olive oil; Dietary Supplement: olive oil and chewing gum; Dietary Supplement: chewing gum; Dietary Supplement: water |
| other surgery | Experimental | all of others abdominal surgical intervention Receives: Dietary Supplement: olive oil; Dietary Supplement: olive oil and chewing gum; Dietary Supplement: chewing gum; Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to flatus
Measured: two days
Secondary outcomes (1)
time to stool
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startApr 2010
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dott.ssa Angela Inviati, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869231
- Sponsor's protocol ID
- 17070401
- Status last verified
- May 2013
- First submitted
- 27 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matros E, Rocha F, Zinner M, Wang J, Ashley S, Breen E, Soybel D, Shoji B, Burgess A, Bleday R, Kuntz R, Whang E. Does gum chewing ameliorate postoperative ileus? Results of a prospective, randomized, placebo-controlled trial. J Am Coll Surg. 2006 May;202(5):773-8. doi: 10.1016/j.jamcollsurg.2006.02.009.
PubMed 16648017Bonventre S, Inviati A, Di Paola V, Morreale P, Di Giovanni S, Di Carlo P, Schifano D, Frazzetta G, Gulotta G, Scerrino G. Evaluating the efficacy of current treatments for reducing postoperative ileus: a randomized clinical trial in a single center. Minerva Chir. 2014 Feb;69(1):47-55.
PubMed 24675245
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus
- ClinicalTrials.gov ID
- NCT01869231
- Acronym / sponsor ID
- 17070401
- Conditions
- Post-operative Ileus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- First posted
- 5 Jun 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.
Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| major surgery | Experimental | Dietary Supplement: olive oil, Dietary Supplement: olive oil and chewing gum, Dietary Supplement: chewing gum, Dietary Supplement: watercolic surgery |
| minor surgery | Experimental | Dietary Supplement: olive oil, Dietary Supplement: olive oil and chewing gum, Dietary Supplement: chewing gum, Dietary Supplement: waterappendectomy; cholecystectomy |
| ileostomy and colostomy | Experimental | Dietary Supplement: olive oil, Dietary Supplement: olive oil and chewing gum, Dietary Supplement: chewing gum, Dietary Supplement: waterileostomy colostomy |
| other surgery | Experimental | Dietary Supplement: olive oil, Dietary Supplement: olive oil and chewing gum, Dietary Supplement: chewing gum, Dietary Supplement: waterall of others abdominal surgical intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent abdominal surgery for non neoplastic diseases
Key exclusion criteria (6 listed)
- Metastatic disease
- History of inflammatory bowel disease
- Postoperative fever
- Gastrointestinal fistula
- Mint or olive allergy; and/or
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 |
|---|---|---|
| olive oil | Dietary supplement | ileostomy and colostomy, major surgery, minor surgery, other surgery |
| olive oil and chewing gum | Dietary supplement | ileostomy and colostomy, major surgery, minor surgery, other surgery |
| chewing gum | Dietary supplement | ileostomy and colostomy, major surgery, minor surgery, other surgery |
| water | Dietary supplement | ileostomy and colostomy, major surgery, minor surgery, other surgery |
Primary outcome
time to flatus
Time frame: two days
1 secondary outcome
time to stool
Time frame: five 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 5 Jun 2013.
- Results publication: PubMed 16648017Matros E, Rocha F, Zinner M, Wang J, Ashley S, Breen E, Soybel D, Shoji B, Burgess A, Bleday R, Kuntz R, Whang E. Does gum chewing ameliorate postoperative ileus? Results of a prospective, randomized, placebo-controlled trial. J Am Coll Surg. 2006 May;202(5):773-8. doi: 10.1016/j.jamcollsurg.2006.02.009.
- Derived from this study: PubMed 24675245Bonventre S, Inviati A, Di Paola V, Morreale P, Di Giovanni S, Di Carlo P, Schifano D, Frazzetta G, Gulotta G, Scerrino G. Evaluating the efficacy of current treatments for reducing postoperative ileus: a randomized clinical trial in a single center. Minerva Chir. 2014 Feb;69(1):47-55.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olive oil, olive oil and chewing gum and chewing gum in people with Post-operative Ileus, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
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 6 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 5 Jun 2013. 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 Italy. 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.
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: two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869231, which also lists 2 linked publications.
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 5 Jun 2013.