NCT01662115

Nicotine Gum Recovery After Colorectal Surgery

Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.

Detailed description

The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.

Conditions

• Post-operative Ileus

Interventions

Type	Name	Description
DRUG	Nicotine gum	Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
OTHER	Regular chewing gum	Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-08-10
• Last updated: 2017-08-22
• Results posted: 2017-08-22

Locations

1 site across 1 country: United States