The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery

NCT ID: NCT01579175

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-02-28

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.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard postoperative care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chewing gum arm

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

Group Type: EXPERIMENTAL

Chewing gum

Intervention Type: OTHER

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

Interventions

Chewing gum

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

Intervention Type: OTHER

Other Intervention Names

Extra spearment sugar free gum

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Catherine Sewell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine A Sewell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Amelia M Jernigan, MD

Role: STUDY_CHAIR

Johns Hopkins University

Grace Chen, MD

Role: STUDY_DIRECTOR

Johns Hopkins Bayview

Locations

Johns Hopkins Bayview

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25147092 (View on PubMed)

Other Identifiers

NA_00036423

Identifier Type: -

Identifier Source: org_study_id