Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
The specific aim of this prospective, randomized controlled trial is to compare the effect of chewing gum on the return of bowel function in a group of patients undergoing spinal surgery with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in time to passage of first flatus will be considered an important clinical difference. The research questions are: Does providing chewing gum post-operatively hasten the return of bowel function? Does providing chewing gum post-operatively reduced overall length of stay? Does providing chewing gum post-operatively have any associated complications? Does providing chewing gum post-operatively result in higher objective outcomes scores? The secondary aims are: To compare hospital length of stay between the groups with a mean of ½ day considered clinically important. To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant. To compare incidence and nature of complications between the two groups. To compare the time until completion of rehab milestones with 1 day being considered clinically important. To compare the requirement for nutrition evaluations To compare SF-12 scores as a marker of patient satisfaction with a difference of 10 points or more measured between the two groups upon discharge from hospital and at six-weeks after surgery.

Official Title
-----------------
Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial

Conditions
-----------------
Return of Bowel Function Following Spinal Surgery

Intervention / Treatment
-----------------
* Dietary Supplement: Chewing gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Lumbar decompression 2+ levels Posterior spinal instrumentation and fusion 1+ levels Combined anterior (ALIF/XLIF) and ANY posterior procedure (ie - decompression +/- fusion) Exclusion Criteria: Age < 18 Trauma Tumor Infection Stand-alone anterior surgery Allergy to chewing gum

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing gum<br>Chewing gum | Dietary Supplement: Chewing gum<br>* Patients will be asked to chew gum three times a day for 30 minutes each time<br>|
| No Intervention: No Chewing Gum<br>No Chewing Gum | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time first pass flatus as a measure of return of bowel function. | Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function. | Up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | Up to two weeks | 
| time until tolerating regular diet |  | Up to two weeks | 
| post-operative narcotic usage |  | Up to two weeks | 
| pre-operative narcotic usage |  | Up to two weeks | 
| incidence complications |  | Up to two weeks | 
| time to completion of rehabilitation criteria for discharge |  | Up to two weeks | 
| requirement for nutrition evaluations |  | Up to two weeks | 
| NRS pain scores |  | Up to two weeks |