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

American University of Beirut Medical Center

Status: Unknown

Conditions: Ileus

Treatments: Dietary Supplement: chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT02847364

SUR.AMST.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Chewing gum group

Experimental group

Description:

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

Treatment:

Dietary Supplement: chewing gum

Control group

No Intervention group

Description:

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.