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Table 1 Study visits of DeloRes

From: DeloRes trial: study protocol for a randomized trial comparing two standardized surgical approaches in rectal prolapse - Delorme’s procedure versus resection rectopexy

 

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

 

Screening

Surgery

Day of Discharge

6 months after Surgery

12 months after Surgery

24 months after Surgery

60 months after Surgery

Demographic and clinical baseline data

×

      

Inclusion/Exclusion

×

      

Randomization

×

      

Intervention

 

×

     

Assessment of Complications and Safety

 

×

×

×

×

×

×

Recurrence

   

×a

×a

×

×

Secondary endpoints

 

×

×

×a

×a

×

 

SF-12

×

  

×a

×a

×

 

Herold constipation score

×

  

×a

×a

×

 

Wexner score

×

  

×a

×a

×

 

Rockwood-FIQLScore

×

  

×a

×a

×

 
  1. aIt is intended that patients come to the trial sites for all follow-up visits. If they are unable to travel they will be visited by a study nurse. At the 6- and 12-month follow-up visits, recurrence status, secondary endpoints can exceptionally be assessed by phone interview and/or by mailing questionnaires.