Conditions: Post-operative Ileus
Keywords: ILEUS
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 4
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 100 subjects who will actually get the intervention medication arm 2: 100 subjects who will be part of a control group arm 3: 100 subjects who will not get neither the intervention nor the placebo gum.

Interventions: intervention 1: Nicotine gum intervention 2: Regular chewing gum
Intervention descriptions: intervention 1: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first intervention 2: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first

Protocol document: