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Clinical Trials/NCT01579175
NCT01579175
Completed
Phase 1

The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.

Johns Hopkins University2 sites in 1 country294 target enrollmentJanuary 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Postoperative Ileus
Sponsor
Johns Hopkins University
Enrollment
294
Locations
2
Primary Endpoint
Time to flatus
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
February 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Sewell

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • Undergoing benign gynecologic surgery via an exploratory laparotomy
  • Capable of giving consent

Exclusion Criteria

  • Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
  • Intubated or unconscious when leaving the OR
  • Bowel resection performed at the time of surgery
  • Active bowel disease (IBD, appendicitis, etc)
  • Gynecologic malignancy

Outcomes

Primary Outcomes

Time to flatus

Time Frame: 30 days

Secondary Outcomes

  • Postoperative ileus(30 days)
  • time to discharge(30 days)
  • time to toleration of diet(30 days)
  • patient satisfaction(30 days)

Study Sites (2)

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