Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery
- Conditions
- Return of Bowel Function Following Spinal Surgery
- Interventions
- Dietary Supplement: Chewing gum
- Registration Number
- NCT02186717
- Lead Sponsor
- Hospital for Special Surgery, New York
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- Age > 18
- Lumbar decompression 2+ levels
- Posterior spinal instrumentation and fusion 1+ levels
- Combined anterior (ALIF/XLIF) and ANY posterior procedure (ie - decompression +/- fusion)
- Age < 18
- Trauma
- Tumor
- Infection
- Stand-alone anterior surgery
- Allergy to chewing gum
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chewing gum Chewing gum Chewing gum
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method length of hospital stay Up to two weeks post-operative narcotic usage Up to two weeks requirement for nutrition evaluations Up to two weeks incidence complications Up to two weeks time to completion of rehabilitation criteria for discharge Up to two weeks NRS pain scores Up to two weeks time until tolerating regular diet Up to two weeks pre-operative narcotic usage Up to two weeks
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States