Effect of Chewing Gum on Post-operative Ileus (GUMPI)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether chewing gum post-operatively decreases the time to first flatus or defecation in patients undergoing spine surgery as a indirect indicator of post-operative ileus.

Detailed Description
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The patients undergoing spine surgery are at risk of developing post-operative ileus, which will lengthen the hospital stay and cause gastrointestinal distress in patients. Post-operative sham feeding in form of chewing a gum seems to increase the functionality of gastro-intestinal tract earlier in patients who have undergone gastro-intestinal and gynecological surgeries. This study will recruit patients undergoing spine surgery at the investigators medical center and allocate them randomly into two equal groups. Patients in one group will be asked to chew gum after surgery and the other group will not be offered anything on chew on. Both groups will be kept nothing per os (NPO) otherwise till the first bowel movement. The first post-operative flatus and defecation time will be recorded as primary measures and other main outcomes will include first post-operative meal, length of stay and presence of ileus. The descriptive parameters of the two groups will also be recorded as related to relevant medical history, surgery, and post-operative care, to adjust for its effect on outcome measures. This study will identify any beneficial effect that chewing gum will have on post-operative ileus development and might be helpful in establishing better post-operative care protocols in patients undergoing spine surgery.

Official Title
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Does Chewing Gum Affect the Incidence of Post-operative Ileus in Patients Undergoing Spine Surgery?

Conditions
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Ileus

Intervention / Treatment
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* Dietary Supplement: chewing gum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 13 years of age or older Patients who will undergo spine decompression, laminectomy (cervical, lumbar and/or thoracic), discectomy, foraminotomy, or corpectomy, with or without arthrodesis, with or without instrumentation. Exclusion Criteria: Less than 13 years of age Patients who have undergone with abdominal surgery within the last month Patients with inability or problems with chewing and/or dysphagia Patients who are expected to be kept intubated after surgery Patients who are allergic to any chewing gum component

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing gum group<br>The patients will be asked to chew on a regular chewing gum starting morning of post-operative day 1 until the first bowel movement. | Dietary Supplement: chewing gum<br>* The patient will chew one piece (1.45g) of regular chewing gum starting morning of post-operative day 1 for 30 minutes each time, three times per day, till the first bowel movement.<br>|
| No Intervention: Control group<br>These patients will not be offered any food/beverage orally. Patients will be asked not to eat or chew anything till the first bowel movement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first flatus time | time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery. | post-operative hospital stay till discharge (up to 5 days) | 
| first defecation time | time of passing the first defecation after surgery, monitored for first defecation for up to 5 days after surgery. | post-operative hospital stay till discharge (up to 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOS | the length of hospital stay (throughout their hospital stay, average of 5 days) | hospital stay (average of 5 days) | 
| Meal time | The time of first tolerable meal after surgery; monitored for first tolerable meal for up to 5 days after surgery. | post-operative hospital stay till discharge (up to 5 days) | 
| post-operative ileus | presence of post-operative ileus; monitored for ileus for up to 5 days after surgery. | post-operative hospital stay till discharge (up to 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chewing gum, prevention