Documentation

TIMING TO MINIMALLY INVASIVE SURGERY AFTER NEOADJUVANT CHEMORADIOTHERAPY FOR RECTAL CANCER: A MULTICENTER RANDOMIZED CONTROLLED TRIAL

Below is the documentation of the Trial:

 

  1. Favorable Opinion CE Coordinating Center
  2. Conditional opinion dissolution
  3. Favorable opinion amendment substudy TiMiSNAR mirna
  4. Study Protocol Version V3.2018_2018_11_28
  5. Synopsis Studio Version V2.2018_2018_11_28

 

 

CRFs, Informed Consent and Patient Information Sheet:

 

    1. Information Sheet / Informed Consent V2.2018_2018_5_7
    2. Information Sheet / Informed Consent V2.2018_2018_5_7 to be registered
    3. Randomization Form V1.2018_2018_3_4
    4. Clinical Information V1.2018_2018_5_7
    5. Endoscopy Form V1.2018_2018_5_7
    6. CT Scan Form V1.2018_2018_5_7
    7. MRI Form V1.2018_2018_5_7
    8. MRI Structured Form baseline V1.2018_2018_3_4
    9. MRI Structured Form post neoad V1.2018_2018_3_4
    10. Neoadjuvant Form V1. 2018_2018_3_4
    11. Operative Form V1.2018_2018_3_4
    12. Pathology Report Form V1.2018_2018_3_4
    13. PostOP Form V1.2018_2018_3_4
    14. 30_days PO Form V1.2018_2018_5_7
    15. Follow up Form V1.2018_2018_3_4
    16. Death Form V1.2018_2018_3_4
    17. SAER Form V1.2018_2018_3_4
    18. Neoadjuvant Exclusion Form V1.2018_2018_3_4
    19. Exclusion Form V2.2018_2018_5_7
    20. Letter MMG_TiMiSNAR V1.2018_2018_3_4

     

     

    Functionality and fatigue questionnaires:

     

    1. SF36 V1.2018_2018_3_4
    2. MFI-20 V1.2018_2018_3_4
    3. IPSS V1.2018_2018_3_4 (men)
    4. IIEF V1.2018_2018_3_4 (men)
    5. FSFI V1.2018_2018_3_4 (women)
    6. LARS V1.2018_2018_3_4
    7. WEXNER Score V1.2018_2018_3_4

     

     

     

TiMiSNAR

TIMING TO MINIMALLY INVASIVE SURGERY AFTER NEOADJUVANT CHEMORADIOTHERAPY FOR RECTAL CANCER: A MULTICENTER RANDOMIZED CONTROLLED TRIAL

© 2018 TiMiSNAR