At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Computed Tomography With Rectal Contrast and Early Endoscopy for the Detection of Anastomotic Leaks After Left Sided Colorectal Resection. A Single Center, Prospective Trial.
In Brief
An observational study evaluating Computer Tomography and Endoscopy for Anastomosis; Complications and 2 related conditions. Completed, enrolled 416 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.