May 08, 2014
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Grant D. Shifflett, MD
Joseph Nguyen, MPH
This study is being done 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
Inclusion
• Adults age > 18 years
• Males and females
• Patients undergoing the following spinal surgeries
• Posterior lumbar decompression 2+ levels
• Posterior fusion with instrumentation 1+ levels
• Anterior lumbar interbody fusion +/- posterior decompression +/- instrumentation and fusion
• Extreme lateral interbody fusion +/- posterior decompression +/- instrumentation and fusion
Exclusion:
• Pediatric patients
• Trauma patients
• Allergy to chewing gum components
Grant D. Shifflett, MD
shifflettg@hss.edu
212.606.1466