E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative infective complications and long term oncological outcome in patients undergoing surgery for colorectal cancer |
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E.1.1.1 | Medical condition in easily understood language |
Post-operative infective complications and long term oncological outcome in patients undergoing surgery for colorectal cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059428 |
E.1.2 | Term | Postoperative infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
The primary objectives of this randomized clinical trial are to evaluate if perioperative SDD can reduce anastomotic leakage rate and other infectious complications while thereby simultaneously improving long-term oncological outcome. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are a decline in reoperation rate, in-hospital mortality, readmission rate, duration of hospital stay and ICU admission, non-infectious complications, improvement of quality of life and reduction of costs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Elective colon and rectal cancer surgery with primary anastomosis
• No evidence of distant metastases (preoperative CT-abdomen and X-thorax or CT-thorax)
• Procedure either with or without diverting stoma
• Both laparoscopic and open surgery
• Informed consent
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E.4 | Principal exclusion criteria |
• Previous colorectal surgery
• Inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• Other malignancy
• Other malignancies in medical history
• Surgery for diverticular disease
• Performance status > ASA 3 (American Society for Anaesthesiologists)
• Expected adverse reactions/allergies for study medication
• Closure of temporary colostomy or ileostomy
• Immunocompromised patients (prednisone)
• Familial adenomatous polyposis coli (FAP; Lynch syndrome), Hereditary Non Polyposis Colorectal Cancer (HNPCC)
• Preoperative evidence of metastases
• Mental disorder/unable to give informed consent
• Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the SELECT trial is anastomotic leakage and/or anastomotic abscess, defined as clinical and/or radiological evidence of anastomotic dehiscence requiring surgical or radiological (re)intervention. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 weeks after the primary operation |
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E.5.2 | Secondary end point(s) |
The following secondary endpoints are formulated:
• Disease free survival at 3 and 5 years
• Other postoperative infectious complications including pneumonia, urinary tract infections, surgical site infections, wound dehiscence, (remote) intra-abdominal abscess
• Non-infectious complications including cardiac failure, cerebrovascular events, deep venous thrombosis
• In-hospital mortality
• Readmission rate
• Reoperation rate
• Duration of hospital stay
• Quality of life (quality adjusted life years)
• In hospital and out-of-hospital costs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 weeks, 3 years and 5 years, depending on end point |
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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 | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 7 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |