NCT01869231

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
Last Updated

June 5, 2013

Status Verified

May 1, 2013

Enrollment Period

2.7 years

First QC Date

May 27, 2013

Last Update Submit

June 4, 2013

Conditions

Post-operative Ileus

Outcome Measures

Primary Outcomes (1)

  • time to flatus

    two days

Secondary Outcomes (1)

  • time to stool

    five days

Other Outcomes (1)

  • length of hospital stay

    seven days

Study Arms (4)

major surgery

EXPERIMENTAL

colic surgery

Dietary Supplement: olive oilDietary Supplement: olive oil and chewing gumDietary Supplement: chewing gumDietary Supplement: water

minor surgery

EXPERIMENTAL

appendectomy; cholecystectomy

Dietary Supplement: olive oilDietary Supplement: olive oil and chewing gumDietary Supplement: chewing gumDietary Supplement: water

ileostomy and colostomy

EXPERIMENTAL

ileostomy colostomy

Dietary Supplement: olive oilDietary Supplement: olive oil and chewing gumDietary Supplement: chewing gumDietary Supplement: water

other surgery

EXPERIMENTAL

all of others abdominal surgical intervention

Dietary Supplement: olive oilDietary Supplement: olive oil and chewing gumDietary Supplement: chewing gumDietary Supplement: water

Interventions

olive oilDIETARY_SUPPLEMENT
ileostomy and colostomymajor surgeryminor surgeryother surgery
olive oil and chewing gumDIETARY_SUPPLEMENT
ileostomy and colostomymajor surgeryminor surgeryother surgery
chewing gumDIETARY_SUPPLEMENT
ileostomy and colostomymajor surgeryminor surgeryother surgery
waterDIETARY_SUPPLEMENT
ileostomy and colostomymajor surgeryminor surgeryother surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients underwent abdominal surgery for non neoplastic diseases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università di palermo

Palermo, Italy

Location

Related Publications (2)

  • 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.

    PMID: 16648017RESULT

  • 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.

    PMID: 24675245DERIVED

Related Links

MeSH Terms

Interventions

Olive OilChewing GumWater

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 5, 2013

Study Start

April 1, 2010

Primary Completion

December 1, 2012

Last Updated

June 5, 2013

Record last verified: 2013-05

Locations

IT(1)