Clinical trial NCT02847364: Effect of Chewing Gum on Post-operative Ileus (GUMPI)
Official title: Does Chewing Gum Affect the Incidence of Post-operative Ileus in Patients Undergoing Spine Surgery?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ileus
Keywords: chewing gum
prevention
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: first flatus time
timeFrame: post-operative hospital stay till discharge (up to 5 days)
measure: first defecation time
timeFrame: post-operative hospital stay till discharge (up to 5 days)
Secondary outcomes:
measure: LOS
timeFrame: hospital stay (average of 5 days)
measure: Meal time
timeFrame: post-operative hospital stay till discharge (up to 5 days)
measure: post-operative ileus
timeFrame: post-operative hospital stay till discharge (up to 5 days)
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Abdel Majid Sheikh Taha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Short 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.
citation: Zhu 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.
citation: Fineberg 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.