Back to resultsEffect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery
Primary Purpose
Postoperative Ileus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugared Chewing Gum (Juicy Fruit)
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Ileus focused on measuring chewing gum, ileus, gastrointestinal function, colorectal surgery, abdominal surgery
Eligibility Criteria
Inclusion Criteria:
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
- American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
Exclusion Criteria:
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
- American Society of Anesthesiologists (ASA) Class IV or V;
- History of abdominal carcinomatosis
- History of radiation enteritis
- Children < 18 or adults > 85 years of age
Sites / Locations
- Cedars Sinai Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sugared Chewing Gum
No Gum
Arm Description
Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time
No gum given, routine postoperative care provided
Outcomes
Primary Outcome Measures
Time (in hours) to tolerating a low residue diet
Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours
Secondary Outcome Measures
Time (in hours) to passage of flatus
Time from end of operation to first passage of flatus (reported by patient)
Time (hours) to first bowel movement
Time (hours) from end of operation to first bowel movement
Daily Appetite Assessment
Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)
Daily pain assessment
Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)
Daily nausea assessment
Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)
Major or Minor Medical and Surgical Complications
Length of postoperative hospitalization in days
Full Information
NCT ID
NCT01559662
First Posted
March 16, 2012
Last Updated
August 14, 2012
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01559662
Brief Title
Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery
Official Title
A Prospective Randomized Controlled Trial of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery in Patients Managed With Early Enteral Feeding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Purpose of this study is to evaluate the effect of gum chewing on recovery of gastrointestinal function in patient undergoing major colorectal surgery. The investigators hypothesize that patients who chew gum after major colorectal surgery will have faster recovery of gastrointestinal function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
chewing gum, ileus, gastrointestinal function, colorectal surgery, abdominal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugared Chewing Gum
Arm Type
Experimental
Arm Description
Patient asked to chew sugared chewing gum postoperative day 1 to 7, 3 times a day, 45 minutes at a time
Arm Title
No Gum
Arm Type
No Intervention
Arm Description
No gum given, routine postoperative care provided
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugared Chewing Gum (Juicy Fruit)
Intervention Description
One stick of gum, 3 times daily from Postoperative day 1 to 7
Primary Outcome Measure Information:
Title
Time (in hours) to tolerating a low residue diet
Description
Time measured from end of operation to patient tolerating 50% of a low residue diet without emesis in 24 hours
Time Frame
30 day postoperative period
Secondary Outcome Measure Information:
Title
Time (in hours) to passage of flatus
Description
Time from end of operation to first passage of flatus (reported by patient)
Time Frame
30 day postoperative period
Title
Time (hours) to first bowel movement
Description
Time (hours) from end of operation to first bowel movement
Time Frame
30 day postoperative period
Title
Daily Appetite Assessment
Description
Patient asked to record appetite on a scale from 0 (no appetite) to 10 (appetite as good as can be)
Time Frame
Postoperative day 1 - 7
Title
Daily pain assessment
Description
Patient asked to rate pain on VAS scale from 0 (no pain) to 10 (pain as bad as can be)
Time Frame
Postoperative day 1 - 7
Title
Daily nausea assessment
Description
Patient asked to rate nausea on a scale from 0 (no nausea) to 10 (nausea as bad as can be)
Time Frame
Postoperative day 1 - 7
Title
Major or Minor Medical and Surgical Complications
Time Frame
30 day postoperative period
Title
Length of postoperative hospitalization in days
Time Frame
Duration of postoperative hospitalization (expected average of 5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy
Exclusion Criteria:
Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
American Society of Anesthesiologists (ASA) Class IV or V;
History of abdominal carcinomatosis
History of radiation enteritis
Children < 18 or adults > 85 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Fleshner, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Sugared Chewing Gum on Gastrointestinal Recovery After Major Colorectal Surgery
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