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

Not Applicable

• Conditions: Ileus
• Interventions: Dietary Supplement: chewing gum

• Registration Number: NCT02847364
• Lead Sponsor: American University of Beirut Medical Center

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17
• Primary Completion: 2023-02
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewing gum group	chewing gum	The patients will be asked to chew on a regular chewing gum starting morning of post-operative day 1 until the first bowel movement.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon