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Table 1 Trial schedule

From: Prophylactic use of dural tenting sutures in elective craniotomies in adults—is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial

 

Study period

Enrolment

Allocation

Post-allocation

Close-out

Time point

Day before the surgery

Day of the surgery

POD 1

POD 1–3

POD 5–7*

POD 30

Enrolment:

Eligibility screen

X

     

Informed consent

X

     

Allocation

X

     

Interventions:

Intervention group

 

X

    

Control group

 

X

    

Assessments:

Basic demographic data acquisition

X

     

Neurological evaluation

X

 

X

 

X

 

CT

   

X

  

Mortality and readmission evaluation

     

X

Radiological evaluation of a CT imaging

     

X

  1. Abbreviations: POD postoperative day, CT computed tomography, NRS Numerical Rating Scale, GCS Glasgow Coma Scale, mRS modified Rankin Scale, MRCs Modified Research Council system, DOB date of birth
  2. *Or earlier if the patient is discharged before POD 5