Development of a warning score for early detection of colorectal anastomotic leakage: Hype or hope?

doi:10.4240/wjgs.v14.i11.1297

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Nov 27, 2022 (publication date) through Apr 23, 2024

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World Journal of Gastrointestinal Surgery

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1948-9366

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Observational Study

World J Gastrointest Surg. Nov 27, 2022; 14(11): 1297-1309
Published online Nov 27, 2022. doi: 10.4240/wjgs.v14.i11.1297

Table 1 Description of assumptions, values, and probabilities for final cost estimation in the decision tree model scenario with adoption of Early ColoRectAL Leakage score on postoperative day

Patient pathway	Assumptions/Observations	€ value	Probability, %
P1	SS and SP of E-CRALL score (Table 5); SS and SP of CT scan[13,21,22]; Full Hospital costs - Ministerial Order nº 254/2018 (Addendum III); Additional Reoperations/CT scan - Ministerial Order nº 254/2018 (Addendum III and IV); LOHS adjustment (reoperation; discharge in advance)	525.10	4.2
P2		1269.70	1.8
P3		379.00	0
P4		499.10	5.3
P5		1243.70	7.9
P6		353.00	80.8

CT: Computed tomography; E-CRALL: Early ColoRectAL Leakage score; LOHS: Length of hospital stay; SP: Specificity; SS: Sensitivity.

Table 2 Patient demographics and clinical and operative characteristics

Characteristic	Group 1, n = 277	Group 2, n = 94	Group 3, n = 25	P value
Age, mean ± SD	68.8 ± 11.3	72.2 ± 14.5	73.6 ± 13.6	0.02^a
Sex, n (%)				0.505
Male	161 (58.1)	59 (62.7)	17 (68.0)
Female	116 (41.9)	35 (37.3)	8 (32.0)
BMI, mean ± SD	26.8 ± 3.99	26.3 ± 4.05	26.0 ± 3.97	0.33
CCI, mean ± SD	5.12 ± 1.83	5.55 ± 2.38	6.04 ± 2.15	0.03^a
ASA score, n (%)				0.018^a
I–II	187 (67.5)	47 (50.0)	13 (45.8)
III–IV	90 (32.5)	47 (50.0)	12 (54.2)
Type of surgery, n (%)				0.071
Elective	238 (86.0)	72 (76.6)	19 (75.0)
Urgent	39 (14.0)	22 (23.4)	6 (25.0)
Surgical approach, n (%)				< 0.001^a
Open	25 (9.0)	15 (16.0)	2 (8.0)
Laparoscopic	238 (86.0)	72 (77.0)	15 (60.0)
Conversion	14 (5.0)	7 (7.4)	8 (32.0)
Procedure, n (%)				0.739
Right colectomy¹	138 (49.8)	47 (50.0)	11 (44.0)
Left colectomy	17 (6.1)	7 (7.4)	1 (4.0)
Sigmoid/RS resection	55 (19.8)	15 (15.9)	4 (16.0)
Low anterior resection	48 (17.3)	16 (17.0)	8 (32.0)
Other	19 (6.8)	9 (9.6)	1 (4.0)
Level of anastomosis, n (%)				0.66
Ileocolic	150 (54.1)	50 (53.2)	11 (44.0)
Colocolic	23 (8.3)	5 (5.3)	1 (4.0)
≥ 6 cm from AV	67 (24.2)	25 (26.6)	10 (40.0)
< 6 cm from AV	37 (13.4)	14 (14.9)	3 (12.0)
Covering stoma, n (%)	23 (8.3)	8 (8.51)	2 (8.0)	0.99
Blood loss in mL, mean ± SD	51.6 ± 36.6	58.8 ± 47.7	104.0 ± 191.1	< 0.001^a
Intraoperative complications, n (%)	3 (1.1)	5 (5.3)	4 (16.0)	< 0.001^a
Operative time in min, mean ± SD	141.9 (48.3)	146.2 (50.0)	172.8 (57.2)	0.011^a
LOHS in d				< 0.001^a
mean ± SD	7.4 ± 2.1	14.3 ± 7.4	24.0 ± 14.0
Median	7	13	21
90-d mortality, n (%)	0 (0)	0 (0)	3 (12.0)	< 0.001^a

^aP < 0.05.

¹Included ileocecal resection/extended right-sided colectomy.

Group 1: No complications; Group 2: Complications not related to colorectal anastomotic leakage; Group 3: Colorectal anastomotic leakage. ASA: American Society of Anesthesiologists; AV: Anal verge; BMI: Body mass index; CCI: Charlson Classification Index; LOHS: Length of hospital stay; RS: Rectosigmoid; SD: Standard deviation.

Table 3 Items weighted for the early ColoRectAL leakage score from postoperative day 3 to 5

E-CRALL score	POD3	POD4	POD5
Body mass index	-0.05142	-0.02927	Not included
Charlson Comorbidity Index score	0.1403	Not included	Not included
Open surgery	Not included	-0.0196	Not included
ASA score III or IV	0.0764	Not included	Not included
Blood loss (in mL)	0.2418	0.2044	0.1426
Operative time (in min)	0.0070	0.0074	0.0041
Anastomosis colocolic	-0.1065	-0.0297	Not included
Intraoperative complications	1.1731	1.378	0.7685
Plasma level of CRP (in mg/L)	0.0099	0.0089	0.0066
Plasma level of CLP (in μg/mL)	0.1333	0.1809	0.4548
Plasma level of ECC (in cell/μL)	Not included	-0.0007	-0.0038
Clinical condition: improved	Not included	-0.6075	-2.199
Abdominal pain (absent/low)	Not included	-1.1150	-0.2843
Abdominal pain (at wound)	-1.19011	-1.845	-1.5299
Abdominal pain (localized)	Not included	Not included	1.2566

ASA: American Society of Anesthesiologists; CLP: Calprotectin; CRP: C-reactive protein; ECC: Eosinophil cell count; E-CRALL: Early ColoRectAL Leakage score; POD: Postoperative day.

Table 4 Sensitivity, specificity, positive predictive value, and negative predictive value for the Early ColoRectAL Leakage score according to the postoperative day

E-CRALL score	POD3	POD4	POD5
Threshold	5.51	2.56	8.29
Sensitivity, %	85.7	100	100
Specificity, %	66.1	69.6	86.6
PPV	13.8	17.2	32.1
NPV	98.7	100	100
CAL diagnosis, %	67.2	71.4	87.4
AUROC (95%CI)	0.82 (0.67-0.96)	0.84 (0.74-0.94)	0.95 (0.90-0.99)

AUROC: Area under the receiver operating characteristic curve; CAL: Colorectal anastomotic leakage; CI: Confidence interval; E-CRALL: Early ColoRectAL Leakage score; NPV: Negative predictive value; POD: Postoperative day; PPV: Positive predictive value.

Table 5 Time to CAL diagnosis and time savings by adopting the Early ColoRectAL Leakage from postoperative day 3 to postoperative day 5

E-CRALL score	POD3	POD4	POD5
Time to CAL diagnosis in d	3.9	4.0	5.0
Expected time saving in d	5.2	5.1	4.1

CAL: Colorectal anastomotic leakage; E-CRALL: Early ColoRectAL Leakage score; POD: Postoperative day.

Table 6 Inpatient episode cost and length of stay based on standard clinical practice vs Early ColoRectAL Leakage score adoption on postoperative day 5

	Non-CAL patients		CAL patients
Cost	Standard	E-CRALL	Standard	E-CRALL
Index costs in €	3177.00	1946.84	9096.00	8176.88
Index LOHS in d	9.1	5.0	24.0	20.0

CAL: Colorectal anastomotic leakage; E-CRALL: Early ColoRectAL Leakage score; LOHS: Length of hospital stay; POD: Postoperative day.

Table 7 Inpatient episode cost analysis adjusted to postoperative day 3 to postoperative day 5

POD	Baseline setting	Model setting
POD3	3532.14	2533.44
POD4		2493.25
POD5		2320.64

POD: Postoperative day.

Table 8 Cost minimization analysis

Cost	Non-CAL patients	CAL patients	All patients
E-CRALL score costs, € (%)	722277.79 (77.9)	204422.00 (22.1)	926699.79
Standard practice costs, € (%)	1143720.00 (82.9)	236496.00 (17.1)	1380216.00
Cost savings, € (%)	421442.20 (92.9)	32074.00 (7.1)	453516.20

CAL: Colorectal anastomotic leakage; E-CRALL: Early ColoRectAL Leakage score.

Table 9 Distinctive aspects of the Dutch Leakage, Adams, Diagnostic Score Leakage, and E-CRALL scores

Aspect	DULK	*Adams et al[12]*	DIACOLE	E-CRALL
Preoperative parameters		X		X
Intraoperative parameters		X		X
Postoperative parameters	X	X	X	X
Method: Points (P)/Threshold (T)/AAN (A)	P	A	T (single)	T (daily)
Predictive ability (AUROC)	NA	0.89	0.91	0.95 (POD5)
Validation: Internal (I)/External (E)	I + E	I+E¹	I	I
Early CAL detection	X			X

¹External validation was obtained from 12 consecutive pilot prospective patients. AUROC: Area under the receiver operating characteristic curve; CAL: Colorectal anastomotic leakage; DIACOLE: Diagnostic Score Leakage; DULK: Dutch Leakage score; E-CRALL: Early ColoRectAL Leakage score; NA: Not available; POD: Postoperative day.

Citation: Rama NJG, Lourenço Ó, Motta Lima PC, Guarino MPS, Parente D, Castro R, Bento A, Rocha A, Castro-Poças F, Pimentel J. Development of a warning score for early detection of colorectal anastomotic leakage: Hype or hope? World J Gastrointest Surg 2022; 14(11): 1297-1309
URL: https://www.wjgnet.com/1948-9366/full/v14/i11/1297.htm
DOI: https://dx.doi.org/10.4240/wjgs.v14.i11.1297