E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative ileus after elective oncological colorectal surgery |
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E.1.1.1 | Medical condition in easily understood language |
Patients who will undergo colorectal operation for cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
primary endpoint time from the end of surgery until first passage of feces
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
secondary endpoint: - First bowel sound, and passage of flatus after surgery - CRP, IL-1, IL-6, TNF-α, white bloodcell ( WBC) level - Postoperative opioid consumption - Patient hospitalization length - Cardiovescular complications |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
no comparator, observation trial (pilot) |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Inclusion of 20 people who complete the full study period. A full study period is from surgery till discharge from the hospital. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |