The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

Phase 1

Completed

• Conditions: Postoperative Ileus
• Interventions: Other: Chewing gum

• Registration Number: NCT01579175
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewing gum arm	Chewing gum	Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes

Primary Outcome Measures

Name	Time	Method
Time to flatus	30 days

Secondary Outcome Measures

Name	Time	Method
Postoperative ileus	30 days	Nausea, vomiting, abdominal distention two episodes of 100cc of emesis
time to discharge	30 days
time to toleration of diet	30 days
patient satisfaction	30 days

Trial Locations

Locations (2)

Johns Hopkins Bayview; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States