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

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

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

^*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.

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