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

NCT ID: NCT02186717

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Return of Bowel Function Following Spinal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chewing gum

Chewing gum

Group Type: EXPERIMENTAL

Chewing gum

Intervention Type: DIETARY_SUPPLEMENT

Patients will be asked to chew gum three times a day for 30 minutes each time

No Chewing Gum

No Chewing Gum

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chewing gum

Patients will be asked to chew gum three times a day for 30 minutes each time

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russel C. Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2014-065

Identifier Type: -

Identifier Source: org_study_id