Does Chewing Gum After Elective Laparoscopic Colectomy Surgery Decrease Ileus?

NCT00632801 | Terminated

• 1 other identifier: 5579
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus

Keywords

elective laparoscopic colectomy; chewing gum; ileus; post-operative care; colectomy

Outcome Measures

Primary Outcomes (1)

• Decrease ileus with intervention compared to standard post op care

  1 year

Study Arms (1)

A

OTHER

Chewing gum or not

Other: chewing gum

Interventions

chewing gum OTHER

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

A

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY UMU

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Ileus

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Melanie Kalmanm, RN PhD

  SUNY UMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Melanie Kalman, PI

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 11, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

US (1)