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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: American University of Beirut Medical Center

Current Primary Outcome:

• first flatus time [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• LOS [ Time Frame: hospital stay (average of 5 days) ]
  the length of hospital stay (throughout their hospital stay, average of 5 days)
• Meal time [ Time Frame: 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.
• post-operative ileus [ Time Frame: 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.

Original Secondary Outcome: Same as current

Information By: American University of Beirut Medical Center

Dates:
Date Received: July 15, 2016
Date Started: February 2016
Date Completion: August 2017
Last Updated: July 27, 2016
Last Verified: July 2016