Postoperative ileus after elective oncological colorectal surgery
Conditions
Interventions
Trade Name: nicorette 2mg chewing gum
Product Name: nicorette 2mg chewing gum
Pharmaceutical Form: Chewable tablet
Sponsors
Erasmus Medical Centre Rotterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this project is to study the effect of nicotine gum chewing in reduction of postoperative ileus (POI) and reduction of opioid use on patients who undergo elective oncological colorectal surgery, and evaluate its safety and possible adverse effects. Primary objective: To investigate the effect of nicotine gum chewing in postoperative bowel motility in patients who undergo oncological colorectal surgery. ;Secondary Objective: Secondary objectives: - Evaluate the effect of nicotine gum chewing on reduction of postoperative opioid consumption on patients who underwent open abdominal surgery. - Evaluate the safety of nicotine gum chewing on patients who undergo colorectal surgery ;Primary end point(s): primary endpoint time from the end of surgery until first passage of feces ;Timepoint(s) of evaluation of this end point: An interim-analysis will be performed on the primary endpoint when 50% of patients have been discharged. An independent statistician, blinded for the treatment allocation, will perform the interim-analysis. The statistician will report to the independent safety-committee. The safety-committee will have unblinded access to all data and will discuss the results of the interim analysis and advice the steering committee. The steering committee will decide on the continuation of the trial. The Peto approach is used: the trial will be ended using symmetric stopping boundaries at P<0,001. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): secondary endpoint: - First bowel sound, and passage of flatus after surgery - CRP, IL-1, IL-6, TNF-a, white bloodcell ( WBC) level - Postoperative opioid consumption - Patient hospitalization length - Cardiovescular complications;Timepoint(s) of evaluation of this end point: An interim-analysis will be performed on the primary endpoint when 50% of patients have been discharged. An independent statistician, blinded for the treatment allocation, will perform the interim-analysis. The statistician will report to the independent safety-committee. The safety-committee will have unblinded access to all data and will discuss the results of the interim analysis and advice the steering committee. The steering committee will decide on the continuation of the trial. The Peto approach is used: the trial will be ended using symmetric stopping boundaries at P<0,001. | — |
Countries
Netherlands
Contacts
Public ContactG.S.A. Boersema, MD, PhD
Erasmus Medical Centre
Outcome results
None listed