Return of Bowel Function Following Spinal SurgeryNCT02186717

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

A study testing Chewing gum in people with Return of Bowel Function Following Spinal Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Return of Bowel Function Following Spinal Surgery
What is being tested?: Chewing gum
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Jun 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

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

The research questions are:

Does providing chewing gum post-operatively hasten the return of bowel function?
Does providing chewing gum post-operatively reduced overall length of stay?
Does providing chewing gum post-operatively have any associated complications?
Does providing chewing gum post-operatively result in higher objective outcomes scores?

The secondary aims are:

To compare hospital length of stay between the groups with a mean of ½ day considered clinically important.
To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant.
To compare incidence and nature of complications between the two groups.
To compare the time until completion of rehab milestones with 1 day being considered clinically important.
To compare the requirement for nutrition evaluations
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
Being tested: Chewing gum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02186717
Study group	Role	What they receive
Chewing gum	Experimental	Chewing gum Receives: Dietary Supplement: Chewing gum
No Chewing Gum	No intervention	No Chewing Gum

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to two weeks

Secondary outcomes (8)

length of hospital stay
Measured: Up to two weeks
time until tolerating regular diet
Measured: Up to two weeks
post-operative narcotic usage
Measured: Up to two weeks
pre-operative narcotic usage
Measured: Up to two weeks
incidence complications
Measured: Up to two weeks
time to completion of rehabilitation criteria for discharge
Measured: Up to two weeks
requirement for nutrition evaluations
Measured: Up to two weeks
NRS pain scores
Measured: Up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Jun 2016

First posted10 Jul 2014 (estimated)
Study startJun 2014
Primary completionDec 2015
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Return of Bowel Function Following Spinal SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02186717
Sponsor's protocol ID: 2014-065
Status last verified: Jun 2023
First submitted: 2 Jul 2014
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT02186717
Acronym / sponsor ID: 2014-065
Conditions: Return of Bowel Function Following Spinal Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: Jun 2014
Primary completion: Dec 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 10 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The research questions are:

Does providing chewing gum post-operatively hasten the return of bowel function?
Does providing chewing gum post-operatively reduced overall length of stay?
Does providing chewing gum post-operatively have any associated complications?
Does providing chewing gum post-operatively result in higher objective outcomes scores?

The secondary aims are:

To compare hospital length of stay between the groups with a mean of ½ day considered clinically important.
To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant.
To compare incidence and nature of complications between the two groups.
To compare the time until completion of rehab milestones with 1 day being considered clinically important.
To compare the requirement for nutrition evaluations
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chewing gum	Experimental	Dietary Supplement: Chewing gumChewing gum
No Chewing Gum	No intervention	–No Chewing Gum

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

Age < 18
Trauma
Tumor
Infection
Stand-alone anterior surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chewing gumPatients will be asked to chew gum three times a day for 30 minutes each time	Dietary supplement	Chewing gum

Primary outcome

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.

8 secondary outcomes

length of hospital stay
Time frame: Up to two weeks
time until tolerating regular diet
Time frame: Up to two weeks
post-operative narcotic usage
Time frame: Up to two weeks
pre-operative narcotic usage
Time frame: Up to two weeks
incidence complications
Time frame: Up to two weeks
time to completion of rehabilitation criteria for discharge
Time frame: Up to two weeks
requirement for nutrition evaluations
Time frame: Up to two weeks
NRS pain scores
Time frame: Up to two weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russel C. Huang, MD principal investigator

Hospital for Special Surgery, New York

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Chewing gum in people with Return of Bowel Function Following Spinal Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time first pass flatus as a measure of return of bowel function. (time frame: Up to two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.