Nicotine Gum Recovery After Colorectal Surgery

Post-operative Ileus Clinical Trial

Official title:

Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01662115
• Other study ID #: CRS-2012-05
• Status: Terminated
• Phase: Phase 4
• First received: August 7, 2012
• Last updated: August 21, 2017
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;

• Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;

Exclusion Criteria:

• Prior intestinal surgery

• Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures

• American Society of Anesthesiologists (ASA) Class IV or V;

• History of abdominal carcinomatosis;

• History of radiation enteritis;

• Children < 18 or adults > 85 years of age

• Pregnant women

• Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago.

• Patients requiring postoperative ventilation, pressor requirement or ICU stay

• Patients with prior cardiovascular disorders

Related Conditions & MeSH terms

• Post-operative Ileus

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel Function Recovery	Time to first bowel movement or flatus	7 days
Secondary	Hospital Stay	Length of postoperative hospital stay	30 days
Secondary	Post-operative Vomiting	Episodes of vomiting	30 days
Secondary	Use of NG Tubes	Nasogastric tube (re)insertions	30 days