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OpenTrials
Completed

NCT Number: NCT02186717

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chewing gum

Dietary Supplement

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

Primary outcomes

  1. Time first pass flatus as a measure of return of bowel function.

    Time frame: Up to two weeks

    Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function.

Secondary outcomes

  1. length of hospital stay

    Time frame: Up to two weeks

  2. time until tolerating regular diet

    Time frame: Up to two weeks

  3. post-operative narcotic usage

    Time frame: Up to two weeks

  4. pre-operative narcotic usage

    Time frame: Up to two weeks

  5. incidence complications

    Time frame: Up to two weeks

  6. time to completion of rehabilitation criteria for discharge

    Time frame: Up to two weeks

  7. requirement for nutrition evaluations

    Time frame: Up to two weeks

  8. NRS pain scores

    Time frame: Up to two weeks

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.