Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?

This study has been terminated.
(Change in procedure nd medication used instead of gum)
Sponsor:
Information provided by (Responsible Party):
Melanie Kalman, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00632801
First received: March 3, 2008
Last updated: December 7, 2014
Last verified: December 2014
  Purpose

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 Intervention
Ileus
Other: chewing gum

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Decrease ileus with intervention compared to standard post op care [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: December 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Chewing gum

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 3, 2008
Last Updated: December 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2015