Nicotine Gum Recovery After Colorectal Surgery

NCT ID: NCT01662115

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-06-30

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.

Conditions

Post-operative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nicotine gum

100 subjects who will actually get the intervention medication

Group Type: ACTIVE_COMPARATOR

Nicotine gum

Intervention Type: DRUG

Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first

regular chewing gum

100 subjects who will be part of a control group

Group Type: SHAM_COMPARATOR

Regular chewing gum

Intervention Type: OTHER

Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first

No gum

100 subjects who will not get neither the intervention nor the placebo gum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nicotine gum

Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first

Intervention Type: DRUG

Regular chewing gum

Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first

Intervention Type: OTHER

Other Intervention Names

Nicorrete gum; Sugarlees chewing gum

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Eric Weiss

DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ERIC G WEISS, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

Cleveland Clinic Florida

Weston, Florida, United States

Countries

United States

Other Identifiers

CRS-2012-05

Identifier Type: -

Identifier Source: org_study_id