Observational Study
Copyright ©The Author(s) 2022.
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, %
P1SS 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)525.104.2
P21269.701.8
P3379.000
P4499.105.3
P51243.707.9
P6353.0080.8
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 ± SD68.8 ± 11.372.2 ± 14.573.6 ± 13.60.02a
Sex, n (%)0.505
Male161 (58.1)59 (62.7)17 (68.0)
Female116 (41.9)35 (37.3)8 (32.0)
BMI, mean ± SD26.8 ± 3.9926.3 ± 4.0526.0 ± 3.970.33
CCI, mean ± SD5.12 ± 1.835.55 ± 2.386.04 ± 2.150.03a
ASA score, n (%)0.018a
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
Elective238 (86.0)72 (76.6)19 (75.0)
Urgent39 (14.0)22 (23.4)6 (25.0)
Surgical approach, n (%)< 0.001a
Open25 (9.0)15 (16.0)2 (8.0)
Laparoscopic238 (86.0)72 (77.0)15 (60.0)
Conversion14 (5.0)7 (7.4)8 (32.0)
Procedure, n (%)0.739
Right colectomy1138 (49.8)47 (50.0)11 (44.0)
Left colectomy17 (6.1)7 (7.4)1 (4.0)
Sigmoid/RS resection55 (19.8)15 (15.9)4 (16.0)
Low anterior resection48 (17.3)16 (17.0)8 (32.0)
Other19 (6.8)9 (9.6)1 (4.0)
Level of anastomosis, n (%)0.66
Ileocolic150 (54.1)50 (53.2)11 (44.0)
Colocolic23 (8.3)5 (5.3)1 (4.0)
≥ 6 cm from AV67 (24.2)25 (26.6)10 (40.0)
< 6 cm from AV37 (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 ± 36.658.8 ± 47.7104.0 ± 191.1< 0.001a
Intraoperative complications, n (%)3 (1.1)5 (5.3)4 (16.0)< 0.001a
Operative time in min, mean ± SD141.9 (48.3)146.2 (50.0)172.8 (57.2)0.011a
LOHS in d< 0.001a
mean ± SD7.4 ± 2.114.3 ± 7.424.0 ± 14.0
Median71321
90-d mortality, n (%)0 (0)0 (0)3 (12.0)< 0.001a
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-0.05142-0.02927Not included
Charlson Comorbidity Index score0.1403Not includedNot included
Open surgeryNot included-0.0196Not included
ASA score III or IV0.0764Not includedNot included
Blood loss (in mL) 0.24180.20440.1426
Operative time (in min)0.00700.00740.0041
Anastomosis colocolic-0.1065-0.0297Not included
Intraoperative complications1.17311.3780.7685
Plasma level of CRP (in mg/L) 0.00990.00890.0066
Plasma level of CLP (in μg/mL)0.13330.18090.4548
Plasma level of ECC (in cell/μL)Not included-0.0007-0.0038
Clinical condition: improvedNot 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 includedNot included1.2566
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
Threshold5.512.568.29
Sensitivity, %85.7100100
Specificity, %66.169.686.6
PPV13.817.232.1
NPV98.7100100
CAL diagnosis, %67.271.487.4
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 d3.94.05.0
Expected time saving in d5.25.14.1
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 €3177.001946.84 9096.008176.88
Index LOHS in d9.15.024.020.0
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
POD33532.142533.44
POD42493.25
POD52320.64
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 parametersXX
Intraoperative parametersXX
Postoperative parametersXXXX
Method: Points (P)/Threshold (T)/AAN (A)PAT (single)T (daily)
Predictive ability (AUROC)NA0.890.910.95 (POD5)
Validation: Internal (I)/External (E) I + EI+E1II
Early CAL detectionXX
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.