Chewing nicotine gum for faster recovery of bowel movement after surgery

• Conditions: Postoperative ileus after elective oncological colorectal surgery; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-003679-36-NL
• Lead Sponsor: Erasmus Medical Centre Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-07
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Elective colorectal surgery because of carcinoma
- >18 years of age
- Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Severe chronic cardiovascular disease or current acute cardiovascular disease
i.e. recent myocard infarct, Prizmetal variant angina, instable angina pectoris, palpitations, recent cerebrovascular accident, intermittent claudication
-Severe liver- or kidney disease
i.e. cirrhosis, hepatitis, less than 40% of kidney function left.
-Oral or pharyngeal infection, esophagitis
- Hypersensitivity to any component of the nicotine gum
- Pregnant/ breast feeding
- Elevated risk of choking for any reason
- Unable to chew gum for any reason
-Previous colorectal surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified