Return of Bowel Function Following Spinal Surgery
Conditions
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: 1. Does providing chewing gum post-operatively hasten the return of bowel function? 2. Does providing chewing gum post-operatively reduced overall length of stay? 3. Does providing chewing gum post-operatively have any associated complications? 4. Does providing chewing gum post-operatively result in higher objective outcomes scores? The secondary aims are: 1. To compare hospital length of stay between the groups with a mean of ½ day considered clinically important. 2. To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant. 3. To compare incidence and nature of complications between the two groups. 4. To compare the time until completion of rehab milestones with 1 day being considered clinically important. 5. To compare the requirement for nutrition evaluations 6. 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.
Interventions
DIETARY_SUPPLEMENTChewing gum
Patients will be asked to chew gum three times a day for 30 minutes each time
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time first pass flatus as a measure of return of bowel function. | Up to two weeks | Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| length of hospital stay | 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 |
| incidence complications | Up to two weeks |
Countries
United States
Outcome results
None listed