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Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus

Primary Purpose

Post-operative Ileus

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
olive oil
olive oil and chewing gum
chewing gum
water
Sponsored by
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Ileus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Università di palermo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

major surgery

minor surgery

ileostomy and colostomy

other surgery

Arm Description

colic surgery

appendectomy; cholecystectomy

ileostomy colostomy

all of others abdominal surgical intervention

Outcomes

Primary Outcome Measures

time to flatus

Secondary Outcome Measures

time to stool

Full Information

First Posted
May 27, 2013
Last Updated
June 4, 2013
Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT01869231
Brief Title
Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Ileus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
major surgery
Arm Type
Experimental
Arm Description
colic surgery
Arm Title
minor surgery
Arm Type
Experimental
Arm Description
appendectomy; cholecystectomy
Arm Title
ileostomy and colostomy
Arm Type
Experimental
Arm Description
ileostomy colostomy
Arm Title
other surgery
Arm Type
Experimental
Arm Description
all of others abdominal surgical intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
olive oil
Intervention Type
Dietary Supplement
Intervention Name(s)
olive oil and chewing gum
Intervention Type
Dietary Supplement
Intervention Name(s)
chewing gum
Intervention Type
Dietary Supplement
Intervention Name(s)
water
Primary Outcome Measure Information:
Title
time to flatus
Time Frame
two days
Secondary Outcome Measure Information:
Title
time to stool
Time Frame
five days
Other Pre-specified Outcome Measures:
Title
length of hospital stay
Time Frame
seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Università di palermo
City
Palermo
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16648017
Citation
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.
Results Reference
result
PubMed Identifier
24675245
Citation
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.
Results Reference
derived
Links:
URL
http://emedicine.medscape.com/article/178948-treatment
Description
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Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus

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