Nicotine Gum Recovery After Colorectal Surgery

NeuroTherapia, Inc.

Status and phase: Terminated; Phase 4

Conditions: Post-operative Ileus

Treatments: Drug: Nicotine gum; Other: Regular chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT01662115

CRS-2012-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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4 participants in 3 patient groups

Nicotine gum

Active Comparator group

Description:

100 subjects who will actually get the intervention medication

Treatment:

Drug: Nicotine gum

regular chewing gum

Sham Comparator group

Description:

100 subjects who will be part of a control group

Treatment:

Other: Regular chewing gum

No gum

No Intervention group

Description:

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