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Table 2 Postoperative outcome parameters and schedule of study visits and follow-up

From: The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial

Outcome parameter Daily in-hospital study visits Follow-up
  POD 1 (24h)* POD 2 to POD 5 ≥ POD6 Discharge 3 months 12 months 36 months
Pain intensity (VAS) X (primary outcome) X X X    
Daily analgesic use X X      
Cumulative analgesic use   X (POD 5)   X X   
Daily patient mobility X X   X    
Cumulative patient mobility     X    
Inflammatory parameters (CRP, leukocytes) X X      
Discharge criteria   X (POD5) X     
Length of stay     X    
Morbidity     X X X X
Return to normal activities      X   
Quality of life (GIQLI[21])      X X X
Sexual function (FSFI[22])      X X X
Cosmetic satisfaction (Body Image Scale[23])      X X X
  1. *Study visit on POD 1 is scheduled 24 hours postoperatively; parameters will be measured solely on POD 5. CRP, C-reactive protein; FSFI, Female Sexual Function Index; GIQLI, Gastrointestinal Quality Of Life Index; POD, postoperative day; VAS, visual analogue scale.