The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery
GumGyn
1 other identifier
interventional
294
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2010
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 14, 2013
March 1, 2013
3.1 years
April 13, 2012
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Time to flatus
30 days
Secondary Outcomes (4)
Postoperative ileus
30 days
time to discharge
30 days
time to toleration of diet
30 days
patient satisfaction
30 days
Study Arms (2)
Standard postoperative care
NO INTERVENTIONChewing gum arm
EXPERIMENTALSugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes
Interventions
Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.
Eligibility Criteria
You may qualify if:
- years or older
- Undergoing benign gynecologic surgery via an exploratory laparotomy
- Capable of giving consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Bayview
Baltimore, Maryland, 21224, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (1)
Jernigan AM, Chen CC, Sewell C. A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery. Int J Gynaecol Obstet. 2014 Dec;127(3):279-82. doi: 10.1016/j.ijgo.2014.06.008. Epub 2014 Jul 21.
PMID: 25147092DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2012
First Posted
April 17, 2012
Study Start
January 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 14, 2013
Record last verified: 2013-03