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

Johns Hopkins University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postoperative Ileus

Treatments: Other: Chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT01579175

NA_00036423

Details and patient eligibility

About

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.

Enrollment: 294 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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294 participants in 2 patient groups

Standard postoperative care

No Intervention group

Chewing gum arm

Experimental group

Description:

Sugar free (extra, spearment) chewing gum given to the patient to chew during waking hours every four hours for 15 minutes

Treatment:

Other: Chewing gum