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V.P. Sazhin

Vishnevsky National Medical Research Center of Surgery;
Pavlov Ryazan State Medical University

A.G. Beburishvili

Volgograd State Medical University

S.I. Panin

Volgograd State Medical University

I.V. Sazhin

Pirogov Russian National Research Medical University

M.P. Postolov

Volgograd State Medical University;
Volgograd Regional Clinical Oncology Dispensary

Influence of the incidence of ulcerative gastroduodenal bleeding on the effectiveness of treatment. Statistical surveillance

Authors:

V.P. Sazhin, A.G. Beburishvili, S.I. Panin, I.V. Sazhin, M.P. Postolov

More about the authors

Journal: Pirogov Russian Journal of Surgery. 2021;(1): 27‑33

Views: 1653

Downloaded: 96


To cite this article:

Sazhin VP, Beburishvili AG, Panin SI, Sazhin IV, Postolov MP. Influence of the incidence of ulcerative gastroduodenal bleeding on the effectiveness of treatment. Statistical surveillance. Pirogov Russian Journal of Surgery. 2021;(1):27‑33. (In Russ., In Engl.)
https://doi.org/10.17116/hirurgia202101127

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Background

Currently, the main indications for stomach surgery in surgical hospitals are complications of peptic ulcer disease [1 — 4]. Advisability of surgery in patients with perforated ulcers and decompensated gastric outlet obstruction is obvious [5, 6]. Complex non-surgical treatment for ulcerative gastroduodenal bleeding has been promoted for the last several decades [7 — 9]. Management of some patients with ulcerative bleeding becomes less aggressive due to conservative treatment with dynamic gastroscopy and combined endoscopic hemostasis [10, 11]. Unfortunately, widespread availability of these approaches in the Russian Federation is constrained by insufficient material base of surgical services in various regions and surgical departments of many hospitals. No statistically confirmed data on conservative therapy in patients with ulcerative gastroduodenal bleeding inhibits the introduction of perspective treatment of these patients.

Objective. To study and substantiate the influence of gastroduodenal ulcerative bleeding rate on treatment outcomes.

Material and methods

We have performed a multiple-center trial based on the annual information of chief surgeons in 17 regions of the Central Federal District. In accordance with primary objective, we analyzed the effect of the incidence of ulcerative gastroduodenal bleeding on surgical activity, overall in-hospital and postoperative mortality. There were 56,233 patients with ulcerative gastroduodenal bleeding for a 5-year period (2014–2018) in the regions of the Central Federal District.

Statistical analysis was carried out using Microsoft Excel 2007 (correlation-regression analysis) and Review Manager 5.3 software packages (meta-analysis of mortality, calculation of odds ratio (OR), 95% confidence interval (95% CI)). The degree of correlation was determined using Chaddock scale. Considering the central limit theorem, we assumed normal distribution of the variables.

Results

Heterogeneity of data was high (I2 93%). Surgical activity ranged from 5.6% to 38.2% in various regions of the Central Federal District (mean 14.9%). Overall in-hospital mortality from ulcerative bleeding in the Central Federal District was 5.5%. According to meta-analysis based on random-effect model, postoperative mortality was 13.4% (1123 out of 8406) (Table 1). Overall in-hospital mortality was 4.1% after complex conservative treatment with gastroscopy and endoscopic hemostasis (1982 out of 47827) (OR 4.1, 95% CI 3.02-5.55, p <0.00001).

Table 1. Meta-analysis of mortality in the groups of surgery and conservative approach

Study or Subgroup

Operated on

Not operated

Odds Ratio

Odds Ratio

Events

Total

Events

Total

Weight M-H (%)

Random, 95*CI

M-H, Random, 95% CI

Yaroslavl

42

214

117

1726

5,9

3,36 [2,28, 4,94]

Tula

38

276

87

1961

5,9

3,44 [2,30, 5,15]

Tver

33

157

115

2016

5,8

5,28 [3,50, 7,96]

Tambov

25

197

31

1972

5,4

9,10 [5,25, 15,77]

Smolensk

43

194

117

1857

5,9

4,24 [2,88, 6,24]

Ryazan

41

181

148

2437

5,9

4,53 [3,08, 6,66]

Orel

31

139

67

1362

5,7

5,55 [3,47, 8,87]

Moscow region

255

1629

284

9332

6,4

5,91 [4,95, 7,07]

Lipetsk

37

455

131

2271

5,9

1,45 [0,99, 2,11]

Kursk

58

280

59

1900

5,9

8,15 [5,53, 12,02]

Kostroma

13

122

33

779

5,0

2,70 [1,38, 5,28]

Kaluga

52

208

225

3488

6,0

4,83 [3,43, 6,80]

Ivanovo

124

459

107

1081

6,2

3,37 [2,53, 4,49]

Voronezh

26

410

54

2342

5,6

2,87 [1,77, 4,64]

Vladimir

88

570

135

6197

6,2

8,20 [6,17, 10,89]

Bryansk

97

660

107

3451

6,2

5,38 [4,03, 7,19]

Belgorod

115

2255

165

3655

6,3

1,14 [0,89, 1,45]

Total (95% CI)

8406

47827

100,0

4,10 [3,02, 5,65]

Total events

1123

1982

Heterogeneity: Tau2=0,37; Chi2=214,34, df=16 (p<0,00001); I2=93%

Test for overall effect: Z=9,07 (p<0,00001)

Operated on

Not operated

According to pooled statistics in the Russian Federation, mean surgical activity for ulcerative gastroduodenal bleeding in 2017-2018 was 18.1%. All regions of the Central Federal District were divided into 2 groups. Surgical activity was high and exceeded the mean value (> 18.1%) only in 2 regions of the Central Federal District (Belgorod, Ivanovo). In other fifteen regions of the Central Federal District, surgical activity was moderate (<18.1%). Overall in-hospital mortality was 6.9% in active surgical approach and 5.3% in moderate surgical activity. Differences were significant (OR 1.3, 95% CI 1.18-1.4, p <0.05) (Fig. 1).

Fig. 1. Overall in-hospital mortality in ulcerative gastroduodenal bleeding.

There was a reverse trend regarding postoperative mortality. This value was higher in regions with moderate surgical activity compared to regions with active surgical approach (15.5% vs. 8.8%) (Fig. 2). Differences were significant (OR 1.9, 95% CI 1.63-2.21, p <0.05).

Fig. 2. Postoperative mortality in ulcerative gastroduodenal bleeding.

Correlation-regression analysis was used to analyze the effect of independent variable X (incidence) on predicted variables Y (overall in-hospital mortality and surgical activity).

According to correlation analysis (Table 2) with Pearson’s test, there was a proportionality of changes in the number of patients with ulcerative gastroduodenal bleeding and overall in-hospital mortality. Correlation coefficient (r = 0.8705) confirmed strong correlation in accordance with Chaddock scale and made it possible to analyze the model of linear relationship between these statistical values.

Table 2. Correlation analysis

CFD regions

Sick (n) — X

Died (n) — Y

%

Belgorod

5 910

280

4,7

Bryansk

4 111

204

5,0

Vladimir

2 752

80

2,9

Voronezh

6 767

223

3,3

Ivanovo

1 540

231

15,0

Kaluga

3 696

277

7,5

Kostroma

901

46

5,1

Kursk

2 180

117

5,4

Lipetsk

2 726

168

6,2

Moscow region

10 961

539

4,9

Orel

1 501

98

6,5

Ryazan

2 618

189

7,2

Smolensk

2 051

160

7,8

Tambov

2 169

56

2,6

Tver

2 173

153

7,0

Tula

2 237

125

5,6

Yaroslavl

1 940

159

8,2

Total

56 233

3105

5,5

Pearson's correlation coefficient — r (PEARSON)

0,8705

According to regression statistics (Table 3, Fig. 3), r2 coefficient determining the value of the established relationship between overall in-hospital mortality and morbidity is 0.7578.

Table 3. Regression analysis

Multiple R

0,870535703

R2

0,757832411

Standardized R2

0,741687905

Standard error

58,50907134

Sample

17

Fig. 3. Morbidity/overall in-hospital mortality regression analysis.

The proposed statistical model explains correlation of overall in-hospital mortality and incidence of ulcerative gastroduodenal bleeding by 75.8%. In 24.2% of cases, variation between these variables is determined by other random deviations.

Additional variance analysis determined positive (variable X1, coefficient = 0.04) correlation (higher morbidity results higher overall in-hospital mortality) and confirmed the fact that other factors also influence overall in-hospital mortality (Y-intersection, coefficient = 49). These factors of unfavorable outcome following bleeding management are comorbidities, initial severe blood loss, etc. [12]. Moreover, we found statistical significance of correlation between overall in-hospital mortality and morbidity (degrees of freedom — 15, expected t-criterion (6.851) was more than critical t-criterion (2.13), p <0.05)). In this case, the compromising factor of the constructed model of linear regression is mean approximation error that characterizes deviation of the calculated values from the actual ones (Ᾱ — 34.4%).

Pearson’s correlation test between surgical activity and incidence of ulcerative gastroduodenal bleeding confirmed strong correlation according to Chaddock scale (r = 0.725) (Table 4).

Table 4. Correlation between the incidence of ulcerative gastroduodenal bleeding and surgical activity

Surgical activity

CFD regions

Sick (n) — X

Surgeries (n) — Y

%

Belgorod

5910

2255

38,2

Bryansk

4111

660

16,1

Vladimir

2752

570

20,7

Voronezh

6767

410

6,1

Ivanovo

1540

459

29,8

Kaluga

3696

208

5,6

Kostroma

901

122

13,5

Kursk

2180

280

12,8

Lipetsk

2726

455

16,7

Moscow region

10 961

1629

14,9

Orel

1501

139

9,3

Ryazan

2618

181

6,9

Smolensk

2051

194

9,5

Tambov

2169

197

9,1

Tver

2173

157

7,2

Tula

2237

276

12,3

Yaroslavl

1940

214

11,0

Total

56 233

8406

14,9

Pearson's correlation coefficient — r (PEARSON)

0,725371

Linear regression model (Table 5, Fig. 4) showed that correlation of surgical activity and incidence of ulcerative gastroduodenal bleeding has a coefficient of determination r2 = 0.526.

Table 5. Regression analysis

Multiple R

0,72537105

R2

0,52616316

Standardized R2

0,494574037

Standard error

410,7196095

Sample

17

Fig. 4. Morbidity/surgical activity regression analysis.

Thus, direct correlation of surgical activity and morbidity in correlation-regression analysis can be explained in about half of cases (52.6%). Other 47.4% of cases (unexplained variance) depend on other random factors. These "random" factors include unavailable gastroscopy and endoscopic hemostasis, insufficient knowledge and experience in endoscopic specialist and surgeon, unreasonably long surveillance of a patient, insufficient equipment of intensive care unit and others. It should be noted that this statistical value is significantly lower than the previously determined relationship between overall in-hospital mortality and incidence of ulcerative gastroduodenal bleeding (r2 = 0.7578). In this case, the proportion of unexplained variance was 24.2%.

Further dispersion analysis revealed moderate positive (variable X1, coefficient = 0.16) influence (higher morbidity results higher surgical activity) and the effect of other unaccounted factors on surgical activity (Y-intersection, coefficient 60.38). We have also determined significance of correlation between surgical activity and incidence of ulcerative gastroduodenal bleeding (degrees of freedom — 15, expected t-criterion (4.081) > critical t-criterion (2.13), p <0.05) and deviation of the expected values from the actual ones according to mean approximation error (Ᾱ — 53.9%).

Discussion

The effectiveness of treatment is determined by achievement of the objective following a particular medical measure in wide clinical practice (A. Cochrane) (cited by V. V. Omelyanovskiy 2019) [13]. Analysis of mortality rates in large arrays of clinical data is necessary to obtain statistical power and minimize the likelihood of type II error followed by false negative conclusions. It is also necessary to take into account the heterogeneity of data obtained from various primary sources.

According to our data, overall in-hospital mortality among patients with ulcerative gastroduodenal bleeding in the Central Federal District is 5.5%. High surgical activity was followed by mortality 4.7 — 15% (mean 6.9%), less aggressive approaches — 2.6 — 8.2% (mean 5.3%).

Oscillations of postoperative mortality are even more common in patients with ulcerative gastroduodenal bleeding. In the regions of the Central Federal District, high surgical activity is followed by postoperative mortality within 5.1 — 27.0% (mean 8.8%), and in the regions with less aggressive surgical strategy — 6.3 — 25.0% (mean 15.5%). There were significant differences in overall in-hospital and postoperative mortality following high surgical strategy and moderate surgical activity. In accordance with this trend, early surgery should be preferred in case of limited possibilities of endoscopic hemostasis in patients with ulcerative gastroduodenal bleeding.

In chronological analysis, the tendency of greater mortality following low surgical activity in regions is not unambiguous. Oscillations of these indicators are different from year to year and vary in a wide range. For example, postoperative mortality was significantly higher (OR 1.33, 95% CI 1.01-1.77, p = 0.04) in moderate surgical activity (19.2%) compared to high activity (9.8%) in 2014-2017. However, this situation has significantly changed in 2018, and postoperative mortality became higher (OR 1.33, 95% CI 1.01-1.77, p <0.05) in active surgical approach (20.4%) compared to more conservative approach (16.1%).

In chronological analysis of clinical material, heterogeneity of data in primary sources (annual information of chief surgeons of the Central Federal District) was 93% (I2, Review Manager 5.3). This result confirms heterogeneity of primary database on mortality in patients with ulcerative gastroduodenal bleeding (especially for postoperative mortality). Multiple concomitant factors can determine such heterogeneity and multidirectional trends in overall in-hospital and, especially, postoperative mortality. The random influence of these factors requires additional assessment. Patient-related and disease-related prognostic factors include various demographic characteristics of patients, comorbidities, course of peptic ulcer disease, and severity of bleeding.

Treatment strategy is an essential factor in addition to type of surgery per se. In our large-scale analysis, overall mortality rate was higher among patients with active surgical strategy compared to endoscopic hemostasis and intensive therapy [14 — 16]. At the same time, there is a downside to this trend. Reduced number of stomach surgeries undoubtedly results a loss of experience in gastric surgery in general surgical hospitals. Therefore, impaired prognosis of surgical treatment may be expected if open correction of complications of peptic ulcer disease is required [17]. We cannot also exclude the influence of other special cofactors, such as insufficient equipment and experience for any variant of endoscopic hemostasis. Unreliability of primary basic information is an important factor too. According to primary database, annual surgical activity in one of the regions of the Central Federal District was 5 times higher than mean statistical value. The causes of such a high sporadic activity in certain regions of the Russian Federation also require a detailed study.

Conclusion

The correlations between the number of patients with ulcerative gastroduodenal bleeding and surgical activity, overall in-hospital and postoperative mortality were established on a large clinical material. In active surgical strategy, overall in-hospital mortality prevails over postoperative one. Conservative approach and endoscopic hemostasis are followed by a reverse trend.

The authors declare no conflicts of interest.

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