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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catherine Sewell, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01579175
First received: April 13, 2012
Last updated: March 13, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Johns Hopkins University:

Primary Outcome Measures:
  • Time to flatus [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

  • time to discharge [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • time to toleration of diet [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • patient satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579175

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Johns Hopkins Bayview
Baltimore, Maryland, United States, 21224
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

No publications provided

Responsible Party: Catherine Sewell, Principal Investigator, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01579175     History of Changes
Other Study ID Numbers: NA_00036423
Study First Received: April 13, 2012
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014