Childhood Adenotonsillectomy Trial

7.5.7 Surgical Monitoring

Complications resulting from surgery beyond the immediate post-operative period will be documented at each institution by a phone call from the project coordinator at months 2 and 5 for the EAT arm and at 10 months and at the 12 month clinical visits for the WWSC arm if surgery was performed. All adverse events which exceed threshold criteria (as defined Appendix C of the protocol and in the master Manual of Procedures), SAEs and those that meet the definition of an unanticipated problem that requires reporting (refer to Appendix C of the protocol) will be captured in the DMS. These data will be tabulated and reports will be generated by the DCC who will disseminate the information to the Director of the SQCC on a biannual basis, unless an SAE has been identified.

If a surgical complication is noted that exceeds expectation of usual care, or any site or surgeon is noted to experience significant deviations from reported national rates (as defined by either the SQCC or the DSMB), Dr. Garetz, Director of SQCC, will initiate an investigation and prepare a report for the DCC, DSMB and Steering Committee as appropriate. Dr. Garetz will present follow-up recommendations to the Steering Committee and actions may include ongoing monitoring, retraining, excluding the participation of specific surgeons, or excluding specific sites. The DSMB will be notified prior to implementation of the recommended follow up plan.