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OpenTrials
Completed

NCT Number: NCT01579175

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.

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Key information

Conditions

Postoperative Ileus

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Johns Hopkins Bayview, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chewing Gum

Other

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

Other names: Extra spearment sugar free gum

Primary outcomes

  1. Time to flatus

    Time frame: 30 days

Secondary outcomes

  1. Postoperative ileus

    Time frame: 30 days

    Nausea, vomiting, abdominal distention two episodes of 100cc of emesis

  2. time to discharge

    Time frame: 30 days

  3. time to toleration of diet

    Time frame: 30 days

  4. patient satisfaction

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: GumGyn

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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