Use of a clinical pathway in laparoscopic gastrectomy for gastric cancer

Table 1 Structure of the clinical pathway for laparoscopic gastrectomy

Activities date	1 d before OP (Admission)	Pre-OP (the day of OP)	Operation(the day of OP)	Post-OP(the day of OP)	POD 1	POD 2	POD 3	POD 4	POD 5 and 6 (D/C)
Nursing care	Admission to room: (1-3 pm)Fluid balanceSurveillance V/SWeight measurement	Room nurse:Fluid balance,Check V/S	Surgical nurse:OP preparation	Room nurse:Fluid balanceCheck V/S,drainage	Room nurse:Fluid balanceCheck V/S,drainage	Room nurse:Fluid balanceCheck V/S,drainage	Room nurse: Fluid balance, Check V/S, Drainage	Room nurse:Check V/S	Room nurse:Check V/S
	Check (Surgeon/anesthesiologist): Preoperative study Written consentProtocol for OP preparation						Remove peripheral line after start of 2nd SD
Activity	Usual	Bed rest	Bed rest	Bed rest	Ambulation	Ambulation	Ambulation	Ambulation	Ambulation
Treatment procedure	Skin preparation No Levin tube Breathing exercises use of IS Bowel preparation: Magcorol solution, 250 mL: Dulcolax supplement, 2 sup		Surgical nurse:Foley catheterInsertion	Breathingexercises: use of IS	Breathing exercises: use of IS	Breathing exercises: use of IS	Breathing exercises: use of ISremove JP		Surgeon:Wound S/OEvaluation on D/C criteria
			Surgeons: OP	Anesthesiologist:PCA (Fentanyl 3000 mg)
Medication		Prophylaxis: TE	Prophylaxis: ATB	Prophylaxis: ATBMucolytic agent	Prophylaxis: TE
				Anesthesiologist: PCA	PCA	PCA
Medication on demand				Pain killer: (IV) Demerol NSAIDs Antiemetics	Pain killer: (IV)Demerol NSAIDs Antiemetics	Pain killer: (IV)Demerol NSAIDs Antiemetics	Pain killer: (IV)Demerol NSAIDs Antiemetics	Pain killer: (Oral) NSAIDs	Pain killer: (Oral) NSAIDs
Laboratory test				Laboratorytest	Laboratory test		Laboratorytest		Laboratorytest
Diet	Usual diet at breakfastNPO after breakfast	NPO	NPO	NPO	SOW: post 24 h OP		LD at breakfastSD after G/O	SD	SD
Education and information	Information on CPPermission		Information on leaving OP room				Education: diet for patient and/or relative	Education: diet for patient and/or relative	Information on D/C

OP: Operation; V/S: Vital signs; IS: Incentive spirometry; NPO: Nil per os; CP: Clinical pathway; TE: Thromboembolic; ATB: Antibiotic; PCA: Patients controlled analgesia; IV: Intravenous; NSAIDs: Nonsteroidal anti-inflammatory drugs; POD: Postoperative day; SOW: Sips of water; JP: Jackson-Pratt; LD: Liquid diet; SD: Soft diet; D/C: Discharge; S/O: Stitch out; G/O: Gas out.

Table 2 Demographic data for the enrolled patients n (%)

Variables		No. of patients (total n = 4800)
Sex	Male:Female	2920:1880 (60.8:39.2)
Age (yr)	mean ± SD	56.7 ± 11.7
BMI (kg/m2)	mean ± SD	23.71 ± 3.0
Anastomosis method	Intra:Extra	2345:2455 (48.9:51.1)
Resection	Distal:Total	4218:582 (87.9:12.1)
Combined OP	None:Yes	4531:269 (94.4:5.6)
Event during OP	None:Yes	4723:77 (98.4:1.6)
Number of comorbidities	0:1:2 and more	3196:1137:467 (66.6:23.7:9.7)
ASA	1:2:3	3025:1549:226 (63.0:32.3:4.7)
Previous Abd. OP history	N:Y	4057:743 (84.5:15.5)
TNM stage	1:2:3	4380:314:106 (91.3:6.5:2.2)

SD: Standard deviation; BMI: Body mass index; Intra: Intracorporeal anastomosis; Extra: Extracorporeal anastomosis; OP: Operation; ASA: American Society of Anesthesiologists; Abd: Abdominal.

Table 3 Events during operation

	Intra (n = 25)	Extra (n = 52)
Anastomosis failure (n = 31)	8	23
Esophagojejunostomy failure	7	9
Gastroduodenostomy failure	1	14
Organ injury (n = 30)	10	20
Spleen injury	6	10
Duodenum	0	5
Small bowel injury	1	1
Colon injury	1	2
Pancreas injury	1	1
Liver injury	1	1
Vessel injury (n = 12)	4	8
Splenic artery injury	2	6
Splenic vein injury	0	1
Common hepatic artery injury	1	1
Proper hepatic artery injury	1	0
Emphysema (n = 4)	3	1

Intra: Intracorporeal anastomosis; Extra: Extracorporeal anastomosis.

Table 4 Clinicopathological characteristics of patients who underwent total laparoscopic gastrectomy (intracorporeal anastomosis) and laparoscopic assisted gastrectomy (extracorporeal anastomosis) n (%)

Variables	Intra (n = 2345)	Extra (n = 2455)	P value1
Sex			0.118
Male	1453 (61.96)	1467 (59.76)
Female	892 (38.04)	988 (40.24)
Age (yr)			0.110
≤ 65	1716 (73.18)	1846 (75.19)
> 65	629 (26.82)	609 (24.81)
BMI (kg/m2)			< 0.001
≤ 25	1490 (63.54)	1835 (74.75)
> 25	855 (36.46)	620 (25.25)
Resection			< 0.001
Distal	2018 (86.06)	2200 (89.61)
Total	327 (13.94)	255 (10.39)
Combined OP			0.958
None	2214 (94.41)	2317 (94.38)
Yes	131 (5.59)	138 (5.62)
Event during OP			0.002
None	2321 (98.98)	2402 (97.84)
Yes	24 (1.02)	53 (2.16)
Number of comorbidities			< 0.001
0	1477 (62.99)	1719 (70.02)
1	588 (25.07)	549 (22.36)
2 and more	280 (11.94)	187 (7.62)
ASA			< 0.001
1	1404 (59.87)	1621 (66.03)
2	822 (35.05)	727 (29.61)
3	119 (5.07)	107 (4.36)
Abd OP history			0.008
None	1949 (83.11)	2108 (85.87)
Yes	396 (16.89)	347 (14.13)
TNM stage			< 0.001
I	2066 (88.10)	2314 (94.26)
II	197 (8.40)	117 (4.77)
III	82 (3.50)	24 (0.98)

¹χ² test. Intra: Intracorporeal anastomosis; Extra: Extracorporeal anastomosis; BMI: Body mass index; OP: Operation; ASA: American Society of Anesthesiologists; Abd: Abdominal.

Table 5 Results of the clinical pathway n (%)

Results	Total (n = 4800)	Intra (n = 2345)	Extra (n = 2455)	P value1
Complete	4038 (84.1)	1967 (83.9)	2071 (84.4)	0.651
Planned	3781 (78.8)	1740 (74.2)	2041 (83.2)
Wanted	257 (5.3)	227 (9.7)	30 (1.2)
Drop	762 (15.9)	378 (16.1)	384 (15.6)
Complication	463 (9.7)	230 (9.8)	233 (9.5)
(readmission)	(54) [(1.1)]	(29) [(1.2)]	(25) [(1.0)]
Observation	299 (6.2)	148 (6.3)	151 (6.1)

¹χ² test comparing proportions of dropouts. Intra: Intracorporeal anastomosis; Extra: Extracorporeal anastomosis.

Table 6 Reasons for dropping out: Early postoperative complications n (%)

	Total (n = 4800)	Intra (n = 2345)	Extra (n = 2455)
Complications	463 (9.7)	230 (9.8)	233 (9.5)
Wound infection	127 (2.6)	41 (1.7)	86 (3.5)
Fluid collection	77 (1.6)	49 (2.1)	28 (1.1)
Anastomosis leakage	57 (1.2)	31 (1.3)	26 (1.1)
Anastomosis stenosis	16 (0.3)	11 (0.5)	5 (0.2)
Luminal bleeding	58 (1.2)	25 (1.1)	33 (1.3)
Extraluminal bleeding	19 (0.4)	10 (0.4)	9 (0.4)
Passage disturbance	20 (0.4)	8 (0.3)	12 (0.5)
Paralytic ileus	24 (0.5)	13 (0.6)	11(0.5)
Mechanical ileus	7 (0.2)	2 (0.1)	5 (0.2)
Medical problem	41 (0.9)	26 (1.1)	15 (0.6)
Internal herniation	5 (0.1)	5 (0.2)	0 (0.0)
Others	12 (0.3)	9 (0.4)	3 (0.1)

Intra: Intracorporeal anastomosis; Extra: Extracorporeal anastomosis.

Table 7 Reasons for dropout: Observation cases n (%)

	Total (n = 4800)	Intra (n = 2345)	Extra (n = 2455)
Observation cases	299 (6.2)	148 (6.3)	151 (6.1)
Laboratory test abnormality	220 (4.6)	107 (4.6)	113 (4.6)
Underlying disease	20 (0.4)	14 (0.6)	6 (0.2)
JP turbid	5 (0.1)	4 (0.2)	2 (0.1)
Due to UGI series	29 (0.6)	10 (0.4)	19 (0.8)
Others	25 (0.5)	13 (0.5)	11 (0.4)

Intra: Intracorporeal anastomosis; Extra: Extracorporeal anastomosis; JP: Jackson-Pratt; UGI: Upper Gastrointestinal.

Table 8 Clinical factors that affect dropout n (%)

	Total	Drop	Univariate		Multivariable1
			OR (95%CI)	P value	OR (95%CI)	P value
Sex				< 0.001		< 0.001
Male	2920	534 (18.29)	1.622 (1.372-1.917)		1.459 (1.228 -1.734)
Female	1880	228 (12.13)	1		1
Age (yr)
≤ 65	3562	462 (12.97)	1		1
> 65	1238	300 (24.23)	2.146 (1.824 -2.525)	< 0.001	1.727 (1.448-2.059)	< 0.001
BMI (kg/m2)
≤ 25	3325	496 (14.92)	1
> 25	1475	266 (18.03)	1.255 (1.066-1.478)	0.006
Anastomosis method
Intra	2345	378 (16.12)	1		1
Extra	2455	384 (15.64)	0.965 (0.826-1.126)	0.651	1.057 (0.900-1.242)	0.499
Resection
Distal	4218	593 (14.06)	1		1
Total	582	169 (29.04)	2.501 (2.050-3.052)	< 0.001	2.444 (1.988-3.005)	< 0.001
Resection group
I-distal	2018	285 (14.12)	1	< 0.001
I-total	327	93 (28.44)	2.417 (1.843 -3.169)	< 0.001
E-distal	2200	308 (14.00)	0.990 (0.832 -1.178)	0.909
E-total	255	76 (29.80)	2.582 (1.920-3.472)	< 0.001
Combined OP
None	4531	694 (15.32)	1		1
Yes	269	68 (25.28)	1.870 (1.404-2.491)	< 0.001	1.731 (1.284-2.334)	< 0.001
OP event
None	4723	732 (15.50)	1		1
Yes	77	30 (38.96)	3.480 (2.187-5.539)	< 0.001	2.558 (1.554-4.212)	< 0.001
Number of comorbidities
0	3196	411 (12.86)	1	< 0.001	1	0.031
1	1137	221 (19.44)	1.635 (1.366 -1.957)	< 0.001	1.179 (0.882 -1.576)	0.266
2 and more	467	130 (27.84)	2.614 (2.082-3.281)	< 0.001	1.564 (1.110-2.204)	0.011
ASA score
1	3025	382 (12.63)	1	< 0.001	1	0.006
2	1549	305 (19.69)	1.696 (1.438-2.000)	< 0.001	1.182 (0.893-1.565)	0.242
3	226	75 (33.19)	3.437 (2.554-4.625)	< 0.001	1.889 (1.271-2.808)	0.002
Abdominal OP history
None	4057	661 (16.29)	1
Yes	743	101 (13.59)	0.808 (0.645-1.013)	0.065
TNM stage
I	4380	688 (15.71)	1	0.274
II	314	51 (16.24)	1.041 (0.763-1.420)	0.802
III	106	23 (21.70)	1.487 (0.930-2.377)	0.097

¹Backward elimination. Logistic regression to predict dropout (= 762/4800). OR: Odd ratio; BMI: Body mass index; Intra/I: Intracorporeal anastomosis; Extra/E: Extracorporeal anastomosis; OP: Operation; ASA: American Society of Anesthesiologists.