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Table 1 Schedule of enrolment, interventions and assessments according to SPIRIT

From: Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial

 

Enrolment

Surgery

Post Surgical Pain Assessment

Follow UP 1 Hospital Discharge

Follow up 2 End of Study

Time Points (t)

t -7 days

t-12 hours

t 0

6 hours

12 hours

24 hours

48 hours

Day 3

Day 7

Eligibility Screening and Allocation

To Treatment Groups

 Obtaining Written Informed Consent

x

        

 Checking In- and Exclusion criteria

x

        

 Web-based Randomisation

 

x

       

 Allocation

  

x

      

Interventions

 No Tamponade Dressing

  

x

      

 Tamponade Dressing

  

x

      

Assessment of Baseline Variables

 Demography

x

        

 Goligher`s Classification of Hemorrhoids

x

        

 Concomitant Medication & Comorbidities

x

 

x

      

 Hemoglobin (as part of the clinical routine)

x

 

x

      

 Pain Prophylaxis and Treatment

  

x

      

 Description of Surgery

  

x

      

Assessment of Outcome Variables

 Change of Concomitant Medication & Comorbidities (including pain medication)

       

x

x

 Pain Prophylaxis and Treatment

       

x

x

 Tamponade Dressing Removal or Insertion

  

x

    

x

x

 Hemoglobin (as part of the clinical routine)

x

 

x

    

x

x

 Pain

x

  

x

x

x

x

x

x

 Quality of Life (EQ5D)

x

      

x

x

 Patient Satisfaction

        

x

 Surgical Revision due to Bleeding

       

x

x

 Adverse events & Serious adverse events

  

x

    

x

x

  1. Legend: Detailed overview of all study time points with description of data collection during enrolment, postsurgical pain assessment and follow up