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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579175
First Posted: April 17, 2012
Last Update Posted: March 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Catherine Sewell, Johns Hopkins University
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579175


Locations
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Sewell, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01579175     History of Changes
Other Study ID Numbers: NA_00036423
First Submitted: April 13, 2012
First Posted: April 17, 2012
Last Update Posted: March 14, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases