Evaluating the Efficacy of Current Treatments for Reducing Postoperative Ileus

Post-operative Ileus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869231
• Other study ID #: 17070401
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: June 4, 2013
• Start date: April 2010

Study information

• Verified date: May 2013
• Source: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Post-operative Ileus

Intervention

Dietary Supplement:
• olive oil

• olive oil and chewing gum

• chewing gum

• water

Locations

Country	Name	City	State
Italy	Università di palermo	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of hospital stay		seven days	Yes
Primary	time to flatus		two days	Yes
Secondary	time to stool		five days	Yes

External Links

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