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CompletedNCT01869231Updated Jun 5, 2013

Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus

An interventional study of olive oil and olive oil and chewing gum in Post-operative Ileus, sponsored by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-06-05.

Sponsored by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.

02

Conditions studied

  • Post-operative Ileus

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03

In context

Ileus

124 studies on the registry are indexed under Ileus; 12 are open to participants now.

This study's enrollment of 360 is above the median of 97 across 106 interventional studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients underwent abdominal surgery for non neoplastic diseases

Exclusion criteria

Exclusion Criteria:

  • Metastatic disease
  • History of inflammatory bowel disease
  • Postoperative fever
  • Gastrointestinal fistula
  • Mint or olive allergy; and/or
  • Earlier abdominal radiation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    major surgery

    colic surgery

    Dietary Supplement: olive oil · Dietary Supplement: olive oil and chewing gum · Dietary Supplement: chewing gum · Dietary Supplement: water

  • Experimental
    minor surgery

    appendectomy; cholecystectomy

    Dietary Supplement: olive oil · Dietary Supplement: olive oil and chewing gum · Dietary Supplement: chewing gum · Dietary Supplement: water

  • Experimental
    ileostomy and colostomy

    ileostomy colostomy

    Dietary Supplement: olive oil · Dietary Supplement: olive oil and chewing gum · Dietary Supplement: chewing gum · Dietary Supplement: water

  • Experimental
    other surgery

    all of others abdominal surgical intervention

    Dietary Supplement: olive oil · Dietary Supplement: olive oil and chewing gum · Dietary Supplement: chewing gum · Dietary Supplement: water

Interventions

  • Dietary supplementolive oil
  • Dietary supplementolive oil and chewing gum
  • Dietary supplementchewing gum
  • Dietary supplementwater
06

What researchers measure

Primary outcomes

  1. time to flatus

    Time frame: two days

Secondary outcomes

  1. time to stool

    Time frame: five days

Other outcomes

  1. length of hospital stay

    Time frame: seven days

07

Study locations

1 site
  • Università di palermo
    Palermo, Italy
08

References and documents

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 16648017 ↗
  • Bonventre 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 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01869231
Lead sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Responsible party
Dott.ssa Angela Inviati (M.D., Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo) — Principal investigator
First posted
Jun 5, 2013
Start date
Apr 2010
Primary completion
Dec 2012
Last update
Jun 5, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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