E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing elective laparoscopic colectomy for either benign or malignant tumour in the right or left colon with intention to cure.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009944 |
E.1.2 | Term | colon cancer |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009946 |
E.1.2 | Term | Colon Cancer Duke's A |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009947 |
E.1.2 | Term | Colon Cancer Duke's B1 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009948 |
E.1.2 | Term | Colon Cancer Duke's B2 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009949 |
E.1.2 | Term | Colon Cancer Duke's C |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009952 |
E.1.2 | Term | Colon Cancer Recurrent |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009953 |
E.1.2 | Term | Colon Cancer Stage I |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009954 |
E.1.2 | Term | Colon Cancer Stage II |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009955 |
E.1.2 | Term | Colon Cancer Stage III |
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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 |
This pilot aims to test the feasibility of a large Randomised Control Trial (RCT). The full RCT is to compare the effectiveness of wound infusion catheter (WIC) and standard epidural analgesia following laparoscopic colectomy (key hole surgery to remove part of the large bowel) within an Enhanced Recovery Programme. The pilot will provide information on rates of recruitment, data collection and descriptive information on the outcome measures to aid power calculations (which tell us how many patients will be needed in the full RCT). It will also test the ability to successfully blind patients and research personnel to group allocation. This means that they will not know which treatment they are having, and hleps prevent the results from being biased. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients undergoing elective laparoscopic colectomy for either benign or malignant tumour in the right, left or transverse colon with intention to cure. 2. Aged 18 or over with Americal Society of Anaesthesiology (ASA) score I, II or III. 3. Able and willing to provide written consent. |
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E.4 | Principal exclusion criteria |
1. Transverse colon or rectal tumour. 2. Locally advanced or widespread disease - stage T4 on CT scan - palpable mass or distant metastasis. 3. Emergency admission or obstruction/perforation of bowel cancer. 4. Inflammatory Bowel Disease (Crohn's or Ulcerative Colitis). 5. Known allergy to local anaesthetic. 6. Multiple Sclerosis or chronic pain requiring regular strong opioid analgesia. 7. Recent history of alcohol or drug abuse. 8. Contraindication to epidural analgesia. 9. Poor cognitive ability. 10. Pregnant patients. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patient reported pain assessment as measured by the Memorial Pain Assessment Card at intervals throughout the patient stay. |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To test feasibility of a large scale randomised controlled trial. |
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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 | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
placebo - saline via wound infusion catheter. Comparator standard epidural analgesia |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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Last visit of the last subject undergoing the trial. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |