A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial

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

Measures	Preoperative	Daily in-hospital study visits							Follow-up
Measures	Preoperative	POD 0^b	POD 1	POD 2	POD 3	POD 4	POD 5	POD ≥6	M1	M3	M6	M9	M12	M15	M18	M21	M24	M30	M36	M42	M48	M54	M60
Inflammatory parameters (WBC, NE %, CRP, IL-6, TNF-α)	X^a	X^c	X^c			X^c
VAS score			X	X	X		X
Short-term recovery^d			X	X	X	X	X	X
Post-voiding residual urine	X^a				X
EORTC QLQ-C30	X^a								X	X	X
EORTC QLQ-CR29	X^a								X	X	X
IPSS	X^a								X	X	X
BIQ									X	X	X
Abdominal incision photograph		X							X	X	X
Physical examination	X^a								X	X	X	X	X	X	X	X	X	X	X	X	X	X	X
CEA, CA72-4, CA19-9	X									X	X	X	X	X	X	X	X	X	X	X	X	X	X
Chest radiography	X									X	X	X	X	X	X	X	X	X	X	X	X	X	X
Liver ultrasonography										X		X		X		X		X		X		X
Abdominal and pelvic CT scan	X										X		X		X		X		X		X		X
Colonoscopy or EUS	X										X		X		X		X		X		X		X
Adverse event		X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X	X

^aPreoperative study visits will be scheduled within 7 days before surgery; ^bThe study visit on POD 0 will be scheduled during and after surgery; ^cInflammatory parameters will be measured at postoperative 4 hours, 24 hours, and 96 hours after skin suture; ^dShort-term recovery, including time to first flatus, time to resuming liquid diet and soft diet, time to ambulating independently and discharge. POD, postoperative day; M, month; WBC, white blood cells; NE %, neutrophil percentage; CRP, C-reactive protein; IL-6, interleukin-6; TNF-α, tumor necrosis factor-α; VAS, visual analogue scale; QLQ-C30, Quality of Life Questionnaire-Core 30; QLQ-CR29, Quality of Life Questionnaire-Colorectal 29; IPSS, International Prostatic Symptom Score; BIQ, Body Image Questionnaire; CEA, carcinoembryonic antigen; CA 72-4, carbohydrate antigen 72-4; CA 19-9, carbohydrate antigen 19-9; CT, computed tomography; EUS, endoscopic ultrasonography

ISSN: 1745-6215