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

NCT02186717 | Completed

• 1 other identifier: 2014-065
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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. 1.Does providing chewing gum post-operatively hasten the return of bowel function?
2. 2.Does providing chewing gum post-operatively reduced overall length of stay?
3. 3.Does providing chewing gum post-operatively have any associated complications?
4. 4.Does providing chewing gum post-operatively result in higher objective outcomes scores?
5. 5.To compare hospital length of stay between the groups with a mean of ½ day considered clinically important.
6. 6.To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant.
7. 7.To compare incidence and nature of complications between the two groups.
8. 8.To compare the time until completion of rehab milestones with 1 day being considered clinically important.
9. 9.To compare the requirement for nutrition evaluations
10. 10.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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Chewing gum

EXPERIMENTAL

Chewing gum

Dietary Supplement: Chewing gum

No Chewing Gum

NO INTERVENTION

No Chewing Gum

Interventions

Chewing gum DIETARY_SUPPLEMENT

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

Chewing gum

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Lumbar decompression 2+ levels
• Posterior spinal instrumentation and fusion 1+ levels
• Combined anterior (ALIF/XLIF) and ANY posterior procedure (ie - decompression +/- fusion)

You may not qualify if:

• Age \< 18
• Trauma
• Tumor
• Infection
• Stand-alone anterior surgery
• Allergy to chewing gum

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Russel C. Huang, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 10, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)