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Table 1 Time and event chart

From: PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial

Nomenclature

Visit 1

Visit 2

Visit 3

Visits 4, 5, and 6

Screening

Treatment

Discharge

Follow-up

 

Screening, baseline

Surgery

Discharge

Follow-up

Informed consent

√

   

Inclusion/exclusion criteria

√

   

Demographic data (sex, age, weight, height, BMI)

√

   

Medical history/concomitant illness

√

   

Physical examination

√

 

√

√

ASA classification

√

   

Vital signs

√

√

  

Body weight and height

√

   

ECG (12 lead)

√

   

Hematology and coagulation parameters

√

 

√

 

Blood chemistry

√

 

√

 

Antibiotic therapy

√

   

Start of LMW heparin

√

   

Concomitant medicationa

√ continuously

Start and end of surgery

 

√

  

Site and length of incision

 

√

  

Peritonitis grade assessment

 

√

  

Peritoneal fluid sampling for microbiological examination

 

√

  

Contamination assessment

 

√

  

Intestinal resection

 

√

  

Stoma creation

 

√

  

Surgical complications

 

√

  

Surgical drain placement

 

√

  

Surgery report

 

√

  

Time of drain removal

  

√

 

Length of stay in hospital

  

√

 

Post-surgical complications

  

√

√

Abdominal wall ultrasound

   

√

Adverse events

√ continuously

  1. aThis includes use of any blood transfusions that should be inserted in the CRF as type (red blood cells. FFP, platelets)