Colic Clinical Trial
Official title:
Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.
1. Quality assurance plan that addresses data validation and registry procedures,
including any plans for site monitoring and auditing.
2. Data checks to compare data entered into the registry against predefined rules for
range or consistency with other data fields in the registry.
3. Source data verification to assess the accuracy, completeness, or representativeness of
registry data by comparing the data to external data sources .
4. Data dictionary that contains detailed descriptions of each variable used by the
registry, including the source of the variable, coding information .
5. Standard Operating Procedures to address registry operations and analysis activities,
such as patient recruitment, data collection, data management, data analysis, reporting
for adverse events, and change management.
6. Sample size assessment to specify the number of participants or participant years
necessary to demonstrate an effect.
7. Plan for missing data to address situations where variables are reported as missing,
unavailable, "non-reported," uninterpretable, or considered missing because of data
inconsistency or out-of-range results
8. Statistical analysis plan describing the analytical principles and statistical
techniques to be employed in order to address the primary and secondary objectives, as
specified in the study protocol or plan
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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