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

Ileus Clinical Trial

— GUMPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02847364
• Other study ID #: SUR.AMST.01
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: American University of Beirut Medical Center
• Contact: Asdghig Der-Boghossian, LD, MS
• Phone: +961-1-350000
• Email: ahd14[@]mail.aub.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ileus

Intervention

Dietary Supplement:
• chewing gum
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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (4)

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. — View 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. — View 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;(2):CD006506. doi: 10.1002/14651858.CD006506.pub3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	LOS	the length of hospital stay (throughout their hospital stay, average of 5 days)	hospital stay (average of 5 days)
Secondary	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)
Secondary	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)