A total of 222 patients met the inclusion criteria and were analyzed. The mean patient age was 54.52 years (SD 11.71). The median body mass index was 31 (IQR 27.12–35.92) kg/m2. Postoperative stages were I in 162 (72.97%) patients, II in 25 (11.26%), III in 30 (13.51%), and IV in 5 (2.25%). Eighty-seven (39.19%) patients underwent lymphadenectomy.
All patients had an IOA. Frozen section biopsy was positive in 80 (36.04%) patients. The IOA was positive for ovarian involvement in 2 (0.9%) patients, uterine serosa involvement in 12 (5.41%), and cervical involvement in 29 (13.06%). Myometrial invasion was superficial in 34 (15.32%) patients, less than 50% deep in 137 (61.71%), and greater than 50% deep in 51 (22.97%). The presurgical tumor grade was grade 1 in 7 (11.11%) patients, grade 2 (73.02%) in 46 patients and grade 3 in 9 (14.29%) patients. In the final pathology report, the median tumor size was 40 mm (IQR 30–35), there was ovarian involvement in 10 (4.5%) patients, uterine serosa involvement in 3 (1.35%), and cervical involvement in 55 (24.77%). Myometrial invasion was superficial in 34 (15.32%) patients, less than 50% gross depth invasion in 133 (59.51%), and greater than 50% gross depth invasion in 55 (24.77%). There was lymph node metastasis in 23 (10.36%) patients (Table 1).
Table 1
Tumor characteristics as reported in the intraoperative assessment and final pathology report, n = 222.
Intraoperative assessment report
|
Positive intraoperative assessment
|
80 (36.04%)
|
Myometrial invasion
|
|
Superficial
|
34 (15.32%)
|
≤ 50%
|
137 (61.71%)
|
> 50%
|
51 (22.97%)
|
Cervical involvement
|
29 (13.06%)
|
Uterine serosa involvement
|
12 (5.41%)
|
Ovarian involvement
|
2 (0.9%)
|
Grade, n = 63 (28.37%)
|
|
1
|
7 (11.11%)
|
2
|
47 (74.6%)
|
3
|
9 (14.29%)
|
Final pathology report
|
Tumor size, mm
|
40 (30–35) †
|
Myometrial invasion
|
|
Superficial
|
34 (15.32%)
|
≤ 50%
|
133 (59.91%)
|
> 50%
|
55 (24.77%)
|
Uterine serosa involvement
|
3 (1.35%)
|
Ovarian involvement
|
10 (4.50%)
|
Cervical involvement
|
55 (24.77%)
|
Lymphovascular permeation
|
41 (18.47%)
|
Lymph node metastasis (n = 89)
|
|
Yes
|
23 (10.36%)
|
No
|
66 (29.73%)
|
† Median (interquartile range).
|
The IOA showed an accuracy of 76.13% when compared with the postoperative assessment. It had an AUC of 0.74 (95% confidence interval [CI] 0.68–0.8), a sensitivity of 65.52%, a specificity of 82.96%, a positive predictive value of 71.25%, and a negative predictive value of 78.87%. Myometrial invasion had an AUC of 0.76 (95% CI 0.69–0.83) and an accuracy of 82.43 when compared with myometrial invasion in the final pathology report. Cervical involvement had an AUC of 0.61 (95% CI 0.55–0.68) and an accuracy of 77.48%. Uterine serosa involvement had an AUC of 0.47 (95% CI 0.46–0.49) and an accuracy of 93.24%. Ovarian involvement had an AUC of 0.55 (95% CI 0.45–0.65) and an accuracy of 95.5% (Table 2).
Table 2
Diagnostic accuracy of intraoperative assessment parameters.
|
N (%)
|
AUC (95% CI)
|
Sen
|
Spe
|
PPV
|
NPV
|
LR+
|
LR-
|
Accuracy
|
Overall IOA +
|
80 (36.04)
|
0.74 (0.68–0.80)
|
65.52
|
82.96
|
71.25
|
78.87
|
3.85
|
0.42
|
76.13
|
Myometrium IOA+
|
55 (24.77)
|
0.76 (0.69–0.83)
|
64.29
|
88.55
|
65.45
|
88.02
|
5.62
|
0.4
|
82.43
|
Cervix IOA +
|
29 (13.06)
|
0.61 (0.55–0.68)
|
30.91
|
92.81
|
58.62
|
80.3
|
4.31
|
0.74
|
77.48
|
Serous IOA +
|
12 (5.41)
|
0.47 (0.46–0.49)
|
0
|
94.52
|
0
|
98.57
|
0
|
1.5
|
93.24
|
Ovarian IOA +
|
2 (0.90)
|
0.55 (0.45–0.65)
|
10
|
99.53
|
50
|
95.9
|
21.19
|
0.9
|
95.5
|
AUC: area under the curve, Sen: sensitivity, Spe: specificity, PPV: positive predictive value, NPV, negative predictive value, LR: likelihood ratio, IOA: Intraoperative assessment
|
A total of 80 (36.04%) patients had positive IOA, and 142 (63.96%) were negative. Lymphadenectomy was performed on 69 (86.25%) patients in the positive IOA group and 18 (12.68%) in the negative IOA group (p < 0.001). There was lymph node metastasis in 16 (20%) patients in the positive IOA group and 7 (4.93%) patients in the negative IOA group (p < 0.001). Regarding intraoperative complications, patients in the positive IOA group had more intraoperative bleeding (375 ml, IQR 80–300) than those in the negative IOA group (150 ml, IQR 200–550) (p < 0.001). Likewise, there were 8 (10%) blood transfusions in the positive frozen section biopsy group and none (0%) in the negative frozen section biopsy group (p < 0.001). There were no differences found regarding age, menarche, menopause, weight, reintervention, stage IV disease, or ICU admission (Table 3).
Table 3
Comparative analysis according to the intraoperative assessment results, n = 222.
|
IOA negative
|
IOA positive
|
P
|
142 (63.96%)
|
80 (36.04%)
|
Age†
|
53.69 ± 11.38
|
55.95 ± 12.2
|
0.166
|
Menopause
|
108 (76.06%)
|
62 (77.50%)
|
0.807
|
Weight, kg‡
|
74.5 (65.5–85.5)
|
68.5 (60-80.5)
|
0.079
|
BMI†
|
32.64 ± 6.74
|
31.13 ± 7.13
|
0.131
|
Surgical stage
|
|
|
|
I
|
120 (84.51%)
|
42 (52.50%)
|
< 0.001
|
II
|
12 (8.45%)
|
13 (16.25%)
|
|
III
|
8 (5.63%)
|
22 (27.50%)
|
|
IV
|
2 (1.41%)
|
3 (3.75%)
|
|
Lymph node metastasis
|
7 (4.93%)
|
16 (20.00%)
|
< 0.001
|
Lymphadenectomy
|
18 (12.68%)
|
69 (86.25%)
|
< 0.001
|
Bleeding, ml‡
|
150 (80–300)
|
375 (200–550)
|
< 0.001
|
Transfusion
|
0 (0.0%)
|
8 (10.0%)
|
< 0.001
|
Reintervention
|
2 (1.41%)
|
3 (3.75%)
|
0.277
|
ICU
|
2 (1.41%)
|
5 (6.25%)
|
0.07
|
Adjuvant therapy
|
44 (30.99%)
|
62 (77.50%)
|
< 0.001
|
Radiotherapy
|
41 (28.87%)
|
58 (72.50%)
|
0.94
|
Chemotherapy
|
8 (5.63%)
|
22 (27.5%)
|
0.049
|
Recurrence of disease
|
7 (4.93%)
|
8 (10.0%)
|
0.156
|
† Mean ± standard deviation.
|
‡ Median (interquartile range).
FSB: frozen section biopsy, BMI: body mass index. ICU: Intensive Care Unit. IOA: Intraoperative assessment.
|
The median follow-up duration was 43.83 (IQR 24.47–65.8) months. The 5-year overall survival rate for all patients was 95.27% (95% CI 89.5–97.9). Patients with a positive IOA had a 5-year overall survival rate of 92.02% (95% CI 79.05–97.1), whereas patients with a negative IOA had a 5-year overall survival rate of 97.7% (95% CI 93.08–99.26) (p = 0.257). Patients who underwent lymphadenectomy had a 5-year overall survival rate of 94.7% (95% CI 83.4–98.4), whereas those who did not undergo lymphadenectomy had a 5-year overall survival rate of 96.18% (95% CI 89.8–98.6) (p = 0.99). Patients with lymph node metastasis had a 5-year overall survival rate of 80.9% (95% CI 65.3–96.5), whereas patients without lymph node metastasis had a 5-year overall survival rate of 97.9% (95% CI 86.4–99.7) (p = 0.04). (Fig. 1)
The 5-year disease-free survival rate was 91.26% for all patients. Patients with a positive IOA had a 5-year disease-free survival rate of 86.03% (95% CI 73.5-92.91), whereas patients with a negative IOA had a 5-year disease-free survival rate of 94.4% (95% CI 87.29–97.62) (p = 0.177). Patients who underwent lymphadenectomy had a 5-year disease-free survival rate of 91.13% (95% CI 80.94-96), whereas patients who did not undergo lymphadenectomy had a 5-year disease-free survival rate of 91.28% (95% CI 82.39–95.79) (p = 0.789). Patients with lymph node disease had a 5-year disease-free survival rate of 91.28% (95% CI 82.39–95.79), whereas patients without lymph node disease had a 5-year disease-free survival rate of 93.9% (95% CI 81.62–98.07). (Fig. 2)