Instructions
We have developed a simple and user friendly electronic Data Entry Management System (DEMS) to ensure secure, easy and accurate data collection obtained from the collaborators of the participating centers.
- Login to the website to access all necessary study documents and submit your cases online. To do so, please type in your username and password at the "User Login" menu available at the ride-side bar of the website.
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Your account login details including your username and password were provided to your by email sent from our study co-PI, Dr. Dimitri Raptis.
- Please ensure that you have carefully read the study protocol before attempting entering cases at our Data Entry Management System (DEMS). To do so, please click on the “Protocol” icon available at the platform.
- To start submitting your cases to our electronic Data Management System (DEMS) please click on the “Submit Cases” link available in the platform.
- The Data Entry Management System (DEMS) consists of a simple electronic form that you may fill in the data for each case. Please ensure to complete as much information as possible / available.
Fields including a red star at the end of the name of the parameter (*) are mandatory to be able to submit each case. For example, each case should be assigned with a unique Case ID. If this information is missing, you will not be able to submit the case.
An other important mandatory field is the “Clavien-Dindo Classification of Postoperative Complications within 90 days postoperatively*”
If the patient did not encounter any complications from operation until hospital discharge, please indicate "None" for all types and grades of complications.
This table (grid) was created to record with a single click the type of as well as the grade of the same complication according to the Clavien-Dindo Classification of Surgical Complications. The rows correspond to specific types of complications and the columns to their associated grade.
For example, if in a case there was only bleeding that was managed surgically, the complication would be Grade 3b as shown below:
Please ensure you include all types and grades of complications in this table.
If you are not familiar with the Clavien-Dindo Classification of Surgical Complications, please ensure that you have first read and understood clearly the different grades available at the link “Clavien-Dindo Classification”.
For additional types of complications not listed in the table, please grade them according to the Clavien-Dindo Classification of Surgical Complications under the parameter names: “Other 1”, “Other 2” etc.
Please ensure that you describe in detail the types of “Other” complications as well as how they were treated in the free text option as shown above. If a case was not associated with any complications, please click on “none” for all types of complications listed in the table above, including the "Others".
- Please ensure to click on the “Submit” button at the end of the form to successfully submit each case you added data for.
- Please click on the “Submit” button only once and wait until your receive the confirmation.
- To submit the next case, click on the “Go back to the form” link shown above or click on the “Submit cases” link available in the main menu or the right side bar of the website.
- If for any reason you would like to access the list of your previous case submissions, please click on the “View your previous submissions.” link available on the top of the form as shown below. Alternatively, you may access your previous submissions by clicking on the "My submitted cases" available on the right side-bar of the platform
Then you will be provided with the list of cases where you may view or edit again.
Please make sure you save your changes by clicking on the “Submit” button at the end of the page.
- We have also made available for your convenience and to ensure unified and accurate data collection several online calculators and available on the right side bar of the website (after having first logged in).
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If you have any questions or something is unclear regarding the study design, protocol or DEMS, please contact Dr. Dimitri Raptis.