An interventional study of chewing gum in Ileus, sponsored by American University of Beirut Medical Center. Status unknown at 1 site in Lebanon. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Prevention
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.
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →American University of Beirut Medical Center is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
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
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.
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.
first flatus time
time of passing the first flatus after surgery; monitored for first flatus for up to 5 days after surgery.
Time frame: 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.
Time frame: post-operative hospital stay till discharge (up to 5 days)
LOS
the length of hospital stay (throughout their hospital stay, average of 5 days)
Time frame: 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.
Time frame: 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.
Time frame: post-operative hospital stay till discharge (up to 5 days)
Plan to share: No
The record gives a start of Feb 2016, a primary completion of Feb 2023 and a completion of Dec 2023. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Chewing Gum
American University of Beirut Medical Center →