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Table 1 Trial visits

From: Minimally Invasive Versus open AbdominoThoracic Esophagectomy for esophageal carcinoma (MIVATE) — study protocol for a randomized controlled trial DRKS00016773

Activity and documentation

Visit 1 (screening)

Visit 2 (surgery)

Visits 3–9 (POD 1–7)

Visit 10 (discharge)

1. Follow-up (POD 30)

2. Follow-up (POD 90)

3.-5. Follow-up (POM 12, 36, 60)

Inclusion and exclusion criteria and informed consent

x

      

Biometric data (*1)

X

      

Medical history and preoperative assessment (*2)

x

      

Oncological baseline data (*3)

x

      

Pain with VAS and analgetic management

x

x

x

    

ASA, ECOG, Revised Cardiac Risk Index, lung function

x

      

Body weight

x

   

x

x

x

Randomization

x

      

Surgery

 

x

     

Surgical analgetic anesthetic documentation (*4)

 

x

     

Documentation of complications:

Dindo-Clavien for CCI within 30 POD

  

x

x

x

  

 Dindo-Clavien for CCI within 90 POD

  

x

x

x

x

 

 further complications (*5)

  

x

x

x

x

x

scores

 QoR-15

x

 

x (on POD 7)

x

x

x

x

 SF-36

x

  

x

x

x

x

 EORTC QLQ-C30 and EORTC QLQ-OES18

x

  

x

x

x

x

Perioperative course

 Length of (single-lung-) ventilation and analgetic extubation

 

x

     

 Epidural catheter management

 

x

x

    

 Hemodynamic medication

 

x

     

 Fluid management

 

x

     

 Blood gas analysis

 

x

     

 Blood count and CRP

x

 

x (selectively)

    

 Catheters (peridural, urine, central venous)

 

x

     

Postoperative course

 Adherence to fast track protocol

 

x

x

    

 Gastric tube and drainage management

 

x

x

    

 Mobilization

  

x

    

 Vegetative functions (passing stool)

  

x

    

 Wound healing/infection

  

x

    

 Diet

 

x

x

x

   

 Length of hospital stay and discharge

   

x

   

Oncological and specific long-term

 Histopathological data (*6)

   

x

   

 GI symptoms (*7)

    

x

x

x

 Adjuvant therapy

    

x

x

x

 Disease-free survival

    

x

x

x

 Local recurrence

    

x

x

x

 Progression-free survival

    

x

x

x

 Overall survival

    

x

x

x

  1. (*1) Including age, body height, and sex
  2. (*2) Including medication and previous surgical intervention
  3. (*3) Including first diagnosis, cTNM status, location relative to Z-line, and neoadjuvant chemo- or radiotherapy
  4. (*4) Including surgeons, experience, procedure, operation time, anastomosis, complications, conversion, and drainages
  5. (*5) Including anastomotic leak, conduit necrosis, chyle leak, and vocal cord injury according to ECCG and surgical site infection according to CDC
  6. (*6) Including entity, pTNM, grading and resection status, number of lymph nodes retrieved, and number of tumor positive lymph nodes
  7. (*7) Including dysphagia and reflux
  8. ASA American Society of Anesthesiologists classification, CCI Comprehensive Complication Index coding complications and related interventions according to the Dindo-Clavien classification, CDC Center for Disease Control and Prevention, CRP C-reactive protein, ECCG Esophagectomy Complications Consensus Group, ECOG Eastern Cooperative Oncology Group score, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, EORTC QLQ-OES18 Computerized adaptive test European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Esophageal Cancer, POD postoperative day, POM postoperative month, QoR-15 Quality of Recovery 15, SF-36 Short-Form 36, VAS visual analog scale of pain. The primary endpoint is displayed in gray