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

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

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 Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Other: Chewing gum

• Study Type: Interventional
• Enrollment (Anticipated): 294
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Extra spearment sugar free gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to flatus	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction		30 days
Postoperative ileus	Nausea, vomiting, abdominal distention two episodes of 100cc of emesis	30 days
time to discharge		30 days
time to toleration of diet		30 days

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimate): April 17, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: NA_00036423