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

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Return of Bowel Function Following Spinal Surgery

Treatments: Dietary Supplement: Chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT02186717

2014-065

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Chewing gum

Experimental group

Description:

Chewing gum

Treatment:

Dietary Supplement: Chewing gum

No Chewing Gum

No Intervention group

Description:

No Chewing Gum