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Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?

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ClinicalTrials.gov Identifier: NCT00632801
Recruitment Status : Terminated (Change in procedure nd medication used instead of gum)
First Posted : March 11, 2008
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The incidence of ileus after laparoscopic colectomy continues to pose complications for the patient, staff, and the healthcare system. Postoperative ileus remains a source of morbidity and a major determinant of length of stay after abdominal surgery. Clinicians have devised strategies that minimize postoperative ileus. Gum chewing, an inexpensive intervention, is theorized to activate the cephalic- vagal reflex and increase the production of gastrointestinal hormones associated with bowel motility. Four studies examining gum chewing as an intervention to prevent ileus were found. These relatively few studies have demonstrated inconsistencies. Because of the small sample size of the four studies and the inconsistencies of the results, there is not enough evidence to change practice. There are no indications of risks associated with gum chewing as an adjunct therapy along with standard postoperative interventions. The purpose of this prospective, randomized control study is to examine if chewing gum in adult patients after elective laparoscopic colectomy decreases ileus compared with standard post-operative care.

Patients will be randomized by weeks admitted and the patients in the gum chewing group (intervention group) will chew one stick of gum the first post-operative day, after the nasogastric tube is removed or if they patient does not have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set intervals: 0900, 1400, and 2100. The gum will be kept in the Accudose cabinet and distributed by the medication nurse. The gum chewing regimen will continue until the first bowel movement. All patients in the non-intervention group will receive standard preoperative and postoperative regimens.

Patient demographics that will be collected include gender, age, current medical condition, pre-operative medications, type of surgery, operative duration in minutes, anesthesia duration in minutes, estimated operative blood loss, whether they had an epidural or a PCA, date and time nasogastric tube was discontinued, length of stay, date of discharge, complications, and whether or not they had an ileus. Patients (if appropriate) and nurses will be instructed on how to complete the bedside bowel record to the nearest hour.


Condition or disease Intervention/treatment
Ileus Other: chewing gum

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?
Study Start Date : December 2007
Primary Completion Date : December 2011
Study Completion Date : December 2011
Arms and Interventions

Arm Intervention/treatment
A
Chewing gum or not
Other: chewing gum
The patients in the gum chewing group (intervention group) will chew one stick of gum the first post-operative day, after the nasogastric tube is removed or if they patient does not have a nasogastric tube, with the head of bed elevated a minimum of 30 degrees for 30 minutes, three times a day at set intervals


Outcome Measures

Primary Outcome Measures :
  1. Decrease ileus with intervention compared to standard post op care [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to one surgical unit (3-1) from November 1, 2007 to August 1, 2008 with a non- emergent laparoscopic colectomy.

Exclusion Criteria:

All patients with:

  • History of metastatic disease
  • History of inflammatory bowel disease
  • Abdominal radiation treatment
  • Mint allergy (the gum is mint flavored)
  • Dentures
  • Nasogastric tube drainage beyond the first postoperative morning
  • More than one bowel anastomosis during this surgery
  • Conversion to pen colectomy
  • Admission to an ICI post-operatively.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632801


Locations
United States, New York
SUNY UMU
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Melanie Kalmanm, RN PhD SUNY UMU
More Information

Responsible Party: Melanie Kalman, Melanie Kalman, PI, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00632801     History of Changes
Other Study ID Numbers: 5579
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Melanie Kalman, State University of New York - Upstate Medical University:
elective laparoscopic colectomy
chewing gum
ileus
post-operative care
colectomy

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases