CDE Detailed Report
Disease: system
Subdomain Name: Surgeries and Other Procedures
CRF: files
Displaying 101 - 114 of 114
Subdomain Name: Surgeries and Other Procedures
CRF: files
Displaying 101 - 114 of 114
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C59124 | Device model name | DevModelName | The name of the model of the device | The name of the model of the device | Lead model | Alphanumeric |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:25:17.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C08018 | Surgery age value | SurgAgeVal | Age of the participant/subject at the time of the selected surgical procedure | Age of the participant/subject at the time of the selected surgical procedure | Age at time of surgery | Numeric Values |
This element is not considered Core. Please refer to the Date of Birth element on the General Demographics form to derive age. If age is necessary to capture on this form, it may be added. |
No references available | Adult | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
0 | 99 | ||||||||
| C59158 | Pulse generator replacement reason other text | PulseGeneratorRplcmntRsnOTH | The free-text field related to 'Pulse generator replacement reason', specifying other text. The reason the pulse generator was replaced during further surgery | The free-text field related to 'Pulse generator replacement reason', specifying other text. The reason the pulse generator was replaced during further surgery | Other, specify | Alphanumeric |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:27:19.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| C59590 | Anterior commissure posterior commissure target z coordinate value | ACPCTrgtZCoordVal | Stereotactic z coordinate with respect to anterior and posterior commissure (brain nuclei) | Stereotactic z coordinate with respect to anterior and posterior commissure (brain nuclei) | AC-PC coordinates for lead tip with respect to midcommissural point (positive values are right, anterior, and superior, negative values are left, posterior, and inferior) z | Numeric Values |
Specify left and right coordinates if procedure is unilateral. Positive values are right, anterior, and superior, negative values are left, posterior, and inferior |
No references available | Adult | Supplemental | 1.00 | 2022-08-18 17:03:51.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C59096 | L-Dopa pre-operative challenge off dopamine agonist duration | LDopaPreOpChllngOffDpmAgnstDur | Duration in hours the participant/subject was off of dopamine agonists as part of the pre-operative L-Dopa challenge | Duration in hours the participant/subject was off of dopamine agonists as part of the pre-operative L-Dopa challenge | Hours of off dopamine agonists | Numeric Values |
Specify which agonists |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:32:41.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hour | |||||||||
| C59135 | Stimulation brain parameter frequency value | StimBrainParamFreqVal | Value of the frequency (Hz) of electric pulses (stimulation) on brain hemisphere | Value of the frequency (Hz) of electric pulses (stimulation) on brain hemisphere | Frequency: Hz | Numeric Values |
This value should be answered in Hertz (Hz). Answer for both left brain and right brain, if applicable |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:37:09.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
hertz | |||||||||
| C08039 | Electrode brain count | ElectrdBrainCt | Count of electrodes introduced in the brain | Count of electrodes introduced in the brain | Number of microelectrodes passed simultaneously | Numeric Values |
Only answer if 'Simultaneous multiple-microelectrode recording' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 4.00 | 2017-04-12 00:00:00.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
0 | 99 | ||||||||
| C08067 | Surgical complication post-operative type | SurgComplicPstOpTyp | Type of post-operative surgical complications experienced by the participant/subject | Type of post-operative surgical complications experienced by the participant/subject | Post-operative | Hemorrhage;Seizure;Other, specify;Ischemic infarct;Delirium | Hemorrhage;Seizure;Other, specify;Ischemic infarct;Delirium | Alphanumeric |
Within 3 months of implantation. Choose only one. Please refer to the General Adverse Event (AE) form for details on reporting surgical complications. The General Adverse Event form should be considered core for clinical trials. If any additional details on the surgical complication are necessary to captured, this form may be used. |
No references available | Adult | Supplemental | 3.10 | 2022-07-29 11:50:23.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59110 | Surgery intra-operative target verify lead placement MRI type | SurgIntraOpTrgtVrfLdPlcmMRITyp | Type of magnetic resonance imaging (MRI) intra-operative target verification in relation to time of lead placement surgery | Type of magnetic resonance imaging (MRI) intra-operative target verification in relation to time of lead placement surgery | MRI | In surgical suite immediately following lead placement;Real time during placement | In surgical suite immediately following lead placement;Real time during placement | Alphanumeric |
Only answer if 'MRI' is answered for 'Intra-operative target verification' |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 09:47:46.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C59147 | Adverse event treatment specify text | AdvEvntTreatmtSpecifyTxt | The free-text field to specify the treatment required for the adverse event other than action taken with study intervention/ treatment | The free-text field to specify the treatment required for the adverse event other than action taken with study intervention/ treatment | Treatment required, specify | Alphanumeric |
If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:06:04.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C59159 | Lead extender replacement manipulation count | LeadExtndrRplcmntMnpltnCt | Count of brain lead extenders replaced or manipulated during further surgery | Count of brain lead extenders replaced or manipulated during further surgery | Other, specify | Numeric Values |
For reason other than infection |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 11:28:03.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C54898 | Surgery procedure minute duration | SurgeryProcedureMinuteDur | Duration in minutes of surgery or procedure | Duration in minutes of surgery or procedure | Total surgical time (incision to closure): minutes | Numeric Values |
Time from incision to closure reported in minutes |
No references available | Adult | Supplemental | 1.10 | 2022-08-18 17:01:53.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
minute | |||||||||
| C59125 | Pulse generator insert count | PulseGeneratorInsertCt | Count of pulse generators inserted | Count of pulse generators inserted | Number of pulse generators inserted | Numeric Values |
No instructions available |
No references available | Adult | Supplemental | 1.00 | 2022-07-28 10:25:58.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Free-Form Entry |
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| C08022 | Imaging magnetic resonance imaging findings result status | ImgMRIFndngResltStat | Results from MRI studies | Results from MRI studies indicator | MRI findings | Abnormal;Normal | Abnormal;Normal | Alphanumeric |
Choose only one |
No references available | Adult | Supplemental | 4.00 | 2022-07-29 11:39:59.0 | Functional Neurosurgery: Deep Brain Stimulation | Surgeries and Other Procedures | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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