Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus

June 4, 2013 updated by: Dott.ssa Angela Inviati, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Aim was to investigate efficacy of current treatments - water, chewing gum, and olive oil, in resolving postoperative ileus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy
        • Università di Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients underwent abdominal surgery for non neoplastic diseases

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to flatus
Time Frame: two days
two days

Secondary Outcome Measures

Outcome Measure
Time Frame
time to stool
Time Frame: five days
five days

Other Outcome Measures

Outcome Measure
Time Frame
length of hospital stay
Time Frame: seven days
seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17070401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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