RecruitingNCT03148054

Computed Tomography Vs. Endoscopy Study

Computed Tomography with Rectal Contrast and Early Endoscopy for the Detection of Anastomotic Leaks After Left Sided Colorectal Resection. a Single Center, Prospective Trial.

Sponsor

Spital Limmattal Schlieren

Enrollment

400 participants

Start Date

Feb 17, 2017

Study Type

OBSERVATIONAL

Conditions

Anastomosis; Complications Colon Disease Leak, Anastomotic

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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 intervention

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Interventions

DEVICEComputer Tomography and Endoscopy

Pelvic CT scan with i.v. and rectal contrast (Siemens Healtheneers, Erlangen, Germany) with the following scan parameters: collimation 0.6 mm, pitch 1.2 mm, CareKV with reference 120 mAs and reference 120 kV, rotation time 0.5 sec. Portal venous phase (individually tailored contrast media injection of Xenetix 300, Guerbet GmbH) and rectal contrast (500cc: 470cc water + 30cc Telebrix® gastro, a water soluble iodinated contrast agent, Guerbet GmbH). Endoscopy takes 5 minutes: A gastroscope with a diameter of 10mm is used for inspection of anus, rectum, anastomosis incl. measurements (distance to dentate line, diameter of anastomosis) and distal part of colon (to rule out ischemia) during short term insufflation of the rectum with CO2. No biopsies are taken. Digital photo documentation will be provided. In case of anastomotic insufficiency: optional sedation of patient and clip closure with endoscopic OTSC (over the scope clip) system.