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The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery (GumGyn)

This study has been completed.
Information provided by (Responsible Party):
Catherine Sewell, Johns Hopkins University Identifier:
First received: April 13, 2012
Last updated: March 13, 2013
Last verified: March 2013
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.

Condition Intervention Phase
Postoperative Ileus Other: Chewing gum Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.

Resource links provided by NLM:

Further study details as provided by Catherine Sewell, Johns Hopkins University:

Primary Outcome Measures:
  • Time to flatus [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Postoperative ileus [ Time Frame: 30 days ]
    Nausea, vomiting, abdominal distention two episodes of 100cc of emesis

  • time to discharge [ Time Frame: 30 days ]
  • time to toleration of diet [ Time Frame: 30 days ]
  • patient satisfaction [ Time Frame: 30 days ]

Estimated Enrollment: 294
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard postoperative care
Experimental: Chewing gum arm
Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes
Other: Chewing gum
Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.
Other Name: Extra spearment sugar free gum


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01579175

United States, Maryland
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Catherine A Sewell, MD, MPH Johns Hopkins University
Study Chair: Amelia M Jernigan, MD Johns Hopkins University
Study Director: Grace Chen, MD Johns Hopkins Bayview
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Catherine Sewell, Principal Investigator, Johns Hopkins University Identifier: NCT01579175     History of Changes
Other Study ID Numbers: NA_00036423
Study First Received: April 13, 2012
Last Updated: March 13, 2013

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 20, 2017