Effect of Chewing Gum on Post-operative Ileus (GUMPI)
GUMPI
Does Chewing Gum Affect the Incidence of Post-operative Ileus in Patients Undergoing Spine Surgery?
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 17, 2022
February 1, 2022
7 years
July 15, 2016
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
LOS
hospital stay (average of 5 days)
Meal time
post-operative hospital stay till discharge (up to 5 days)
post-operative ileus
post-operative hospital stay till discharge (up to 5 days)
Study Arms (2)
Chewing gum group
EXPERIMENTALThe patients will be asked to chew on a regular chewing gum starting morning of post-operative day 1 until the first bowel movement.
Control group
NO INTERVENTIONThese patients will not be offered any food/beverage orally. Patients will be asked not to eat or chew anything till the first bowel movement.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American University of Beirut Medical Center
Beirut, 11-236, Lebanon
Related Publications (4)
Jennings JK, Doyle JS, Gilbert SR, Conklin MJ, Khoury JG. The Use of Chewing Gum Postoperatively in Pediatric Scoliosis Patients Facilitates an Earlier Return to Normal Bowel Function. Spine Deform. 2015 May;3(3):263-266. doi: 10.1016/j.jspd.2014.12.001. Epub 2015 Apr 23.
PMID: 27927468BACKGROUNDShort V, Herbert G, Perry R, Atkinson C, Ness AR, Penfold C, Thomas S, Andersen HK, Lewis SJ. Chewing gum for postoperative recovery of gastrointestinal function. Cochrane Database Syst Rev. 2015 Feb 20;2015(2):CD006506. doi: 10.1002/14651858.CD006506.pub3.
PMID: 25914904BACKGROUNDZhu YP, Wang WJ, Zhang SL, Dai B, Ye DW. Effects of gum chewing on postoperative bowel motility after caesarean section: a meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):787-92. doi: 10.1111/1471-0528.12662. Epub 2014 Mar 14.
PMID: 24629205BACKGROUNDFineberg SJ, Nandyala SV, Kurd MF, Marquez-Lara A, Noureldin M, Sankaranarayanan S, Patel AA, Oglesby M, Singh K. Incidence and risk factors for postoperative ileus following anterior, posterior, and circumferential lumbar fusion. Spine J. 2014 Aug 1;14(8):1680-5. doi: 10.1016/j.spinee.2013.10.015. Epub 2013 Oct 31.
PMID: 24184650BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdel Majid Sheikh Taha, MD
American University of Beirut Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor of Orthopedic Surgery
Study Record Dates
First Submitted
July 15, 2016
First Posted
July 28, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2023
Study Completion
December 1, 2023
Last Updated
February 17, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share