Hospital for Special Surgery
New York, 10021, United States
NCT Number: NCT02186717
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.
Looking for future studies?
Notify Me18 year–90 year
All sexes
Interventional
Not applicable
New York, 10021, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be asked to chew gum three times a day for 30 minutes each time
Time frame: 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.
Time frame: Up to two weeks
Time frame: Up to two weeks
Time frame: Up to two weeks
Time frame: Up to two weeks
Time frame: Up to two weeks
Time frame: Up to two weeks
Time frame: Up to two weeks
Time frame: Up to two weeks
Hospital for Special Surgery, New York
Other
Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.