The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 294
- Locations
- 2
- Primary Endpoint
- Time to flatus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Standard postoperative care
Chewing gum arm
Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes
Intervention: Chewing gum (Other)
Outcomes
Primary Outcomes
Time to flatus
Time Frame: 30 days
Secondary Outcomes
- Postoperative ileus(30 days)
- time to discharge(30 days)
- time to toleration of diet(30 days)
- patient satisfaction(30 days)
Investigators
Catherine Sewell
Principal Investigator
Johns Hopkins University