Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery

Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Return of Bowel Function Following Spinal Surgery
• Intervention / Treatment: Dietary supplement: Chewing gum

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chewing gum	Dietary supplement: Chewing gum; Patients will be asked to chew gum three times a day for 30 minutes each time
No Intervention: No Chewing Gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time first pass flatus as a measure of return of bowel function.	Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function.	Up to two weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
length of hospital stay	Up to two weeks
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
incidence complications	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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Russel C. Huang, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimated): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2014-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO