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Table 1 Schedule of enrolment, interventions and assessments

From: Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial

  

Study period

 

Enrolment and allocation

Post-allocation

Close-out

Timepoint (months)

 

Surgery

Follow-up after surgery

 

0

1

2.5

4

7

13

25

Enrolment:

       

 Eligibility screen

X

      

 Informed consent

X

      

 Allocation

X

      

Interventions:

       

 MIE with cervical anastomosis

 

X

     

 MIE with intrathoracic anastomosis

 

X

     

Assessments:

       

 Baseline patient characteristics

X

      

 Baseline tumour characteristics

X

      

 QOL questionnaires

X

 

X

X

X

X

X

 CE questionnaires

X

  

X

X

X

X

 Postoperative outcome data

 

X

     

 Pathology data

 

X

     

 Functional recovery data

 

X

X

X

X

X

X

 Oncologic follow-up data

  

X

X

X

X

X

  1. QOL quality of life, CE cost-effectiveness