The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

Postoperative Ileus Clinical Trial

— GumGyn  

Official title:

The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579175
• Other study ID #: NA_00036423
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 13, 2012
• Last updated: March 13, 2013
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

Other:
• Chewing gum
Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to flatus		30 days	No
Secondary	Postoperative ileus	Nausea, vomiting, abdominal distention two episodes of 100cc of emesis	30 days	Yes
Secondary	time to discharge		30 days	No
Secondary	time to toleration of diet		30 days	No
Secondary	patient satisfaction		30 days	No