Clinical trial NCT02186717: Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery
Official title: Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Return of Bowel Function Following Spinal Surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time first pass flatus as a measure of return of bowel function.
timeFrame: Up to two weeks
Secondary outcomes:
measure: length of hospital stay
timeFrame: Up to two weeks
measure: time until tolerating regular diet
timeFrame: Up to two weeks
measure: post-operative narcotic usage
timeFrame: Up to two weeks
measure: pre-operative narcotic usage
timeFrame: Up to two weeks
measure: incidence complications
timeFrame: Up to two weeks
measure: time to completion of rehabilitation criteria for discharge
timeFrame: Up to two weeks
measure: requirement for nutrition evaluations
timeFrame: Up to two weeks
measure: NRS pain scores
timeFrame: Up to two weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Russel C. Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: