NCT03148054 Computed Tomography Vs. Endoscopy Study
| NCT ID | NCT03148054 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spital Limmattal Schlieren |
| Condition | Anastomosis; Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2017-02-17 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Patients undergoing elective surgery for left-sided colon resection are asked to participate in this study: Every patient undergoes two types of examinations (endoscopy, CT scan) on day 3, 4 or 5 postoperatively. These two procedures are subject to investigation in terms of their accuracy (sensitivity, specificity) in detection of anastomotic leaks. The patients are followed up until day 42 postoperatively. There are no other specific tests or examinations within the study. Information and informed consent are obtained preoperatively.
Eligibility Criteria
Inclusion Criteria: * Laparoscopic or open left sided colorectal resection with primary anastomosis (left hemicolectomy, sigmoid resection, anterior resection, segmental resection) and subtotal colectomy with anastomosis * Male and Female patients \>18 years of age * Signed Informed Consent after being informed * Elective surgery Exclusion Criteria: * Formation of a stoma during the initial operation * For i.v. contrast CT scan: creatinine \> 110 umol/l and/or glomerular filtration rate GFR \< 45 ml/min, measured in the standard blood test on postoperative day 2 * Women who are pregnant. Women of childbearing age are regularly tested for possible pregnancy. Pregnancy tests are performed in the hospital at no charge * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Participation in another study with an investigational drug within the 30 days preceding and during the present study * Emergency in