Development of a scoring scale for predicting the risk of postoperative complications after spinal tuberculosis debridement: a retrospective cohort study of 233 patients
Introduction
Spinal tuberculosis (STB) is common extrapulmonary tuberculosis, accounting for about 50% of osteoarticular tuberculosis (1). At present, anti-tuberculosis (TB) drug therapy combined with surgical treatment is considered the gold standard for STB treatment (2). The debridement of lesions is a key step in STB surgery as it enhances the control of tuberculosis changes, improves the efficacy of anti-TB drugs, promotes bone graft fusion, and reduces the risk of recurrence of STB (3,4).
However, debridement is an iatrogenic trauma for patients. In addition, most STB patients have comorbidities such as diabetes, anemia, and hypoalbuminemia, and thus, they have a significantly higher risk of postoperative complications than other patients with degenerative diseases (5-7). Therefore, minimizing complications after debridement is a key focus in STB surgery. Recently, research on postoperative complications of STB has been confined to specific complications such as nerve injury, postoperative intestinal obstruction, and others. However, these studies did not explore the risk factors for other complications and therefore have little significance for the prediction and risk assessment of postoperative complications in spinal tuberculosis patients. Several studies have determined that preoperative albumin values, preoperative comorbidities, and operation time are risk factors of postoperative complications in STB (7-9). These latter studies only examined the role of a single factor in predicting postoperative complications, and thus, an accurate assessment of complication risk cannot be conducted when patients have only some of these risk factors. In addition, to date, there is a paucity of large sample studies reporting the incidence of complications after STB (7-12).
This study retrospectively examined the case data of STB patients who underwent debridement surgery in our hospital to identify the risk factors of postoperative complications. The relative contribution of various risk factors was assessed using quantitative methods to establish a predictive scoring scale of postoperative complications. This scale was established to predict the risk of postoperative complications in STB patients.
We present the following article in accordance with the TRIPOD reporting checklist (available at https://dx.doi.org/10.21037/apm-21-851).
Methods
This study was conducted in accordance with the Declaration of Helsinki (as revised in 2013) and was approved by the Institutional Ethics Board of The First Affiliated Hospital of Chongqing Medical University (No. ChiCTR1800019109). All participants provided written informed consent to participate in this study.
Patient selection
A total of 232 patients with STB who underwent lesion debridement in our hospital from January 2012 to May 2020 were retrospectively included in this study.
Inclusion criteria
Patients were selected if they met the following inclusion criteria: (I) medical records were complete, including general information, preoperative laboratory examination, imaging results [including magnetic resonance imaging (MRI) and computed tomography (CT)], and clinical data on postoperative complications; (II) patients who underwent surgical treatment; and (III) lesion tissues were extracted during the surgery, and postoperative pathological diagnosis was confirmed as STB.
Exclusion criteria
Patients were excluded if they presented with the following: (I) suspected STB not confirmed by pathological examination; (II) preliminary and pathological diagnosis of diseases other than STB; or (III) a previous history of STB.
Measures and outcomes
Measures
Based on previous studies and our experience, the following possible predictors for the occurrence of postoperative complications in STB patients were assessed: patient's general conditions, laboratory examination indexes, and imaging examination indexes. Measures of general patient conditions included age, gender, height, body weight, body mass index (BMI), comorbidities, history of drinking, history of smoking, surgical approach, operation time, operative blood loss, course of disease, and postoperative hospital stay. Laboratory examination indexes included preoperative hemoglobin, preoperative serum albumin, preoperative lymphocytes, preoperative erythrocyte sedimentation rate (ESR), and preoperative C-reactive protein (CRP). Imaging examination indexes included Cobb angle correction and the number of fixation segments. Postoperative complications included operation-related complications (such as low serum albumin, anemia, high fever, cerebrospinal fluid leakage, delirium, delayed wound healing or infection, rupture of iliac vein, and internal fixation instability), anti-TB chemotherapy-related complications (such as abnormal liver function, abnormal kidney function, and limb nerve symptoms), stay-in-bed-related complications (such as gastrointestinal symptoms, electrolyte disorders, thrombus, and urinary tract infections), and others complications (such as restricted respiratory function, respiratory failure, and pleural effusion).
Development of the scoring scale
All included patients were divided into two groups according to the presence or absence of postoperative complications (POCs). Patients experiencing POCs were assigned the “with POC group”, and those without POCs were assigned into the “without POC group”.
Univariate analyses were conducted on the general conditions, laboratory examination indexes, and imaging examination indexes of patients in the two groups to identify possible predictors of POCs. Multivariate logistic regression analyses were subsequently performed to identify the predictors POCs in STB patients. These indicators were then used to develop the scoring scale.
Statistically significant continuous variables (preoperative serum albumin and operation time) were converted to dichotomous variables using receiver operating characteristic (ROC) curves analysis. The weighted score of each item was determined based on the relative size of the P-value according to the method reported by Kharbanda et al. and Zhou et al. (13,14).
The appropriate cut-off points for the scoring scale were determined using ROC curves corresponding to the curve nearest the ROC graph’s upper left corner.
Follow up: validation of the scoring scale
From June 2020 to March 2021, a total of 62 STB patients were enrolled to validate the accuracy of the scoring scale. The inclusion and exclusion criteria for the validation set were identical to the criteria of the derivation set.
Clinicians followed up with all patients through phone communications and outpatient consultations. No clinical data were lost from any of the included patients.
Statistical analysis
The ROC curves analysis determined both the threshold values for continuous variables and the appropriate cut-off points for the scoring scale. The prevalence of the included clinical characteristics was evaluated by calculating the sensitivity and specificity for each factor. The clinical characteristics were also subjected to univariate logistic regression analysis, and the significant factors were evaluated by multivariate logistic regression analysis. The items of the scoring system were determined by multivariate logistic regression, and the weighted score of each item was based on the relative size of the P value. P<0.05 was considered statistically significant. The SPSS version 23.0 software was used for statistical analyses.
Results
Patient population
Among the 232 patients enrolled in the study, 188 patients presented with postoperative complications, including 102 males and 86 females. A total of 44 patients, including 27 males and 17 females, did not have any postoperative complications (Table 1). The various complications experienced are shown in Table 2. The mean ages of patients with and without postoperative complications were 48.75±16.32 and 41.57±14.83 years, respectively (Table 1).
Table 1
| Characteristics | With POC (n=188, 81.0%) | Without POC (n=44, 19.0%) | P value |
|---|---|---|---|
| Age (year) | 48.75±16.32 | 41.57±14.83 | 0.008* |
| Sex (n, %) | 0.393 | ||
| Female | 86 (83.5) | 17 (17.5) | |
| Male | 102 (79.1) | 27 (20.9) | |
| Height (cm) | 162.07±6.67 | 163.39±6.65 | 0.241 |
| Body weight (kg) | 55.90±10.40 | 60.09±10.59 | 0.017* |
| BMI (kg/m2) | 21.23±3.40 | 22.51±3.70 | 0.028* |
| Comorbidities (n, %) | |||
| Diabetes | 29 (96.7) | 1 (3.3) | 0.010* |
| Pulmonary tuberculosis | 79 (94.1) | 5 (5.9) | <0.001* |
| Smoking history (year) | 8.61±1.00 | 3.61±0.98 | 0.001* |
| Drinking history (year) | 5.02±0.80 | 3.05±1.22 | 0.180 |
| Surgery approach (n, %) | 0.038* | ||
| Anterior approach surgery | 21 (95.5) | 1 (4.5) | |
| Posterior approach surgery | 167 (79.5) | 43 (20.5) | |
| Operation time (min) | 212.21±56.11 | 169.93±46.26 | <0.001* |
| Operation blood loss (mL) | 417.73±340.20 | 220.71±135.66 | <0.001* |
| Postoperative hospital stay (day) | 20.56±8.59 | 16.55±8.19 | 0.005* |
| Preoperative hemoglobin (×10) | 119.67±16.79 | 128.73±14.36 | 0.001* |
| Preoperative lymphocytes (×10) | 1.21±0.44 | 1.38±0.55 | 0.061 |
| Preoperative serum albumin (g/L) | 38.69±4.14 | 41.93±3.01 | <0.001* |
| Preoperative CRP (mg/L) | 33.57±34.29 | 21.85±20.37 | 0.004* |
| Preoperative ESR (mm/h) | 56.75±26.54 | 50.02±33.02 | 0.213 |
| Cobb angle correction (°) | 9.33±7.91 | 6.70±6.82 | 0.043* |
| Number of fixation segments | 4.73±1.32 | 4.11±1.19 | 0.005* |
| Course of disease (month) | 11.99±30.05 | 6.97±11.03 | 0.278 |
*, P<0.05. POC, postoperative complication; BMI, body mass index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate.
Table 2
| Complications | Number |
|---|---|
| Total | 188 |
| Low serum albumin | 99 |
| Anemia | 72 |
| High fever | 28 |
| Gastrointestinal symptoms | 25 |
| Cerebrospinal fluid leakage | 9 |
| Electrolyte disorders | 10 |
| Abnormal liver function | 18 |
| Abnormal kidney function | 4 |
| Delirium | 2 |
| Limb nerve symptoms | 14 |
| Drug side effect | 8 |
| Thrombus | 3 |
| Urinary tract infection | 2 |
| Wound delayed healing or infection | 10 |
| Restricted respiratory function | 1 |
| Pleural effusion | 4 |
| Rupture of iliac vein | 1 |
| Internal fixation instability | 1 |
| Respiratory failure | 1 |
Results of univariate and multivariate logistic regression analysis
Univariate logistic regression analysis found that age, BMI, diabetes mellitus, pulmonary tuberculosis, smoking history, preoperative serum albumin, preoperative CRP, Cobb angle correction, anterior surgical approach, operation time, and perioperative blood loss were all risk factors for postoperative complications (Table 3). Multivariate logistic regression analysis on the above significant risk factors revealed that diabetes mellitus, pulmonary tuberculosis, preoperative serum albumin, anterior surgical approach, and operation time were independent risk factors for the incidence of postoperative complications (Table 4). ROC curves showed that the diagnostic threshold of preoperative serum albumin was 40 g/L (sensitivity: 0.841; specificity: 0.559) and the threshold of operation time was 181 minutes (sensitivity: 0.702, specificity: 0.659) (Figure 1).
Table 3
| Characteristics | Crude odds ratio (OR) | 95% CI | P value |
|---|---|---|---|
| Age | 1.028 | 1.007–1.050 | 0.009* |
| Sex | 0.747 | 0.382–1.461 | 0.394 |
| BMI | 0.904 | 0.825–0.990 | 0.030* |
| Diabetes mellitus | 1.128 | 0.017–0.963 | 0.046* |
| Pulmonary tuberculosis | 1.177 | 0.067–0.469 | <0.001* |
| Smoking history | 1.042 | 1.005–1.081 | 0.026* |
| Course of disease | 1.021 | 0.987–1.056 | 0.228 |
| Number of diseased vertebrae | 0.914 | 0.690–1.211 | 0.533 |
| Preoperative hemoglobin | 0.965 | 0.944–0.986 | 0.052 |
| Preoperative lymphocytes | 0.477 | 0.242–0.941 | 0.063 |
| Preoperative serum albumin | 0.782 | 0.702–0.871 | <0.001* |
| Preoperative CRP | 1.018 | 1.002–1.034 | 0.032* |
| Cobb angle correction | 1.056 | 1.001–1.115 | 0.048* |
| Surgery approach | |||
| Anterior approach surgery | 5.786 | 2.089–16.027 | 0.001* |
| Posterior approach surgery | 0.463 | 0.195–1.102 | 0.082 |
| Operation time | 1.018 | 1.010–1.027 | <0.001* |
| Operation blood loss | 1.005 | 1.002–1.007 | <0.001* |
*, P<0.05. BMI, body mass index; CRP, C-reactive protein; OR, odds ratio.
Table 4
| Characteristics | Adjusted odds ratio (OR) | Regression coefficients (β) | 95% CI | P value |
|---|---|---|---|---|
| Age | 1.013 | 0.014 | 0.984–1.045 | 0.360 |
| BMI | 0.928 | −0.079 | 0.811–1.051 | 0.226 |
| Diabetes mellitus | 1.110 | −2.211 | 0.0128–0.964 | 0.046* |
| Pulmonary tuberculosis | 1.185 | −1.687 | 0.063–0.542 | 0.002* |
| Smoking history | 1.050 | 0.048 | 0.993–1.100 | 0.058 |
| Preoperative serum albumin | 0.789 | −0.199 | 0.713–0.941 | 0.005* |
| Cobb angle correction | 0.824 | −0.006 | 0.937–1.061 | 0.924 |
| Anterior approach surgery | 5.934 | 1.781 | 1.126–26.917 | 0.035* |
| operation time | 1.018 | 0.018 | 1.009–1.031 | <0.001* |
| Operation blood loss | 1.001 | 0.001 | 0.998–1.004 | 0.491 |
*, P<0.05. BMI, body mass index; OR, odds ratio.
Development of the scoring scale
The five clinical characteristics identified using the multivariate analysis above were used to develop the scoring scale. According to the P value, diabetes mellitus (P=0.046) and anterior surgical approach (P=0.035) were assigned 1 point; pulmonary tuberculosis (P=0.002) and preoperative serum albumin (P=0.005) were assigned 2 points; and operation time (P<0.001) was assigned 3 points (Table 5). The ROC curve showed that the diagnostic threshold score of the scoring scale was 4 points (sensitivity: 0.654, specificity: 0.864) (Figure 2).
Table 5
| Scoring item | Score |
|---|---|
| Diabetes mellitus | |
| Yes | 1 |
| No | 0 |
| Pulmonary tuberculosis | |
| Yes | 2 |
| No | 0 |
| Preoperative serum albumin | |
| ≤40 | 2 |
| >40 | 0 |
| Anterior approach surgery | |
| Yes | 1 |
| No | 0 |
| Operation time | |
| 181 | 0 |
| >181 | 3 |
Validation of the scoring scale
The scoring scale was applied to 62 patient cases in the validation set. A comparison of the results of the score scale using the derivation set and the validation set is shown in Table 5. Based on the threshold value of 4 points, the sensitivity and specificity of the score for predicting STB postoperative complication were 65.4% and 86.4% in the derivation set, respectively, and 60.8% and 81.8% in the validation set, respectively (Table 6).
Table 6
| Groups | Derivation set | Validation set | |||||
|---|---|---|---|---|---|---|---|
| With POC | Without POC | Total | With POC | Without POC | Total | ||
| Clinical diagnosis | |||||||
| With POC | 123 | 64 | 187 | 33 | 17 | 50 | |
| Without POC | 6 | 39 | 45 | 1 | 11 | 12 | |
| Total | 129 | 103 | 232 | 34 | 28 | 62 | |
| Sensitivity (%) | 65.4 | 60.8 | |||||
| Specificity (%) | 86.4 | 81.8 | |||||
POC, postoperative complication.
Risk prediction of the scoring scale
Based on the existing medical records of the 232 cases, the incidence of postoperative complications was obtained for each score in the score table (Table 7). A corresponding nomogram was created to facilitate the risk assessment of the scoring scale (Figure 3).
Table 7
| Score | Patients with POC | Total patients | Incidence of POC (%) |
|---|---|---|---|
| 0 | 9 | 24 | 37.5 |
| 1 | 6 | 11 | 54.5 |
| 2 | 19 | 28 | 67.9 |
| 3 | 30 | 40 | 75.0 |
| 4 | 25 | 27 | 92.6 |
| 5 | 58 | 61 | 95.1 |
| 6 | 9 | 9 | 100 |
| 7 | 27 | 27 | 100 |
| 8 | 4 | 4 | 100 |
| 9 | 1 | 1 | 100 |
POC, postoperative complication.
Discussion
In the present study, logistic regression analysis revealed that diabetes mellitus, pulmonary tuberculosis, low preoperative serum albumin values, anterior surgical approach, and long operation time were independent risk factors for postoperative complications in STB patients.
Clinical findings: comorbidities
Diabetes mellitus was identified as an independent risk factor for postoperative complications in STB, and STB patients complicated with diabetes were more likely to have postoperative complications. Diabetes has been associated with an increased risk of postoperative infections, postoperative blood transfusions, higher hospitalization costs, and longer hospital stays for patients who undergo spinal surgery (15), which was consistent with our findings. Sharma et al. found that patients with diabetes who underwent spinal surgery have significantly higher rates of postoperative complications and longer hospital stays (16). Previous studies on diabetes in surgical patients mainly focused on the specific clinical outcomes or complications; for example, satisfactory preoperative blood glucose management can reduce the incision infection rate and reduce the morbidity and mortality of patients in intensive care (17). In our study, blood glucose levels were maintained at 6–10 mmol/L by normative preoperative insulin regulation in all diabetic patients. Despite this, diabetes mellitus was still an independent risk factor for overall postoperative complications, suggesting that good preoperative blood glucose control in STB patients with diabetes can only reduce the occurrence of some specific complications, with little effect on the overall incidence of postoperative complications.
Pulmonary tuberculosis was also identified as an independent risk factor for postoperative complications of STB. An epidemiological study reported that 25.7% of STB patients are complicated by pulmonary tuberculosis (18). The increased incidence of postoperative complications in STB patients with pulmonary tuberculosis may be related to the increased burden of pulmonary tuberculosis on the body. Compared with patients with STB alone, patients with multi-site tuberculosis have poorer nutritional status, weaker immune function, and less tolerance to surgery (19,20), and these factors may contribute to a higher risk of overall postoperative complications.
Laboratory test: preoperative serum albumin values
This study demonstrated that preoperative serum albumin value is a risk factor for complications after spinal tuberculosis debridement, which is consistent with previous studies. Studies by Adogwa et al. and Kumar et al. found that preoperative albumin levels less than 35 g/L is an independent risk factor for complications after elective degenerative and malformed spinal fusion (21,22). In contrast, this current study determined that preoperative albumin values less than 40 g/L is an independent risk factor for overall postoperative complications. Two reasons may explain the higher preoperative serum albumin requirements in patients with STB. First, patients with STB are prone to be malnourished, and disease and surgery can increase the likelihood of postoperative complications (18). Second, STB debridement causes more blood loss and requires longer operation times than spinal degenerative disease surgery, and thus patients are more likely to experience complications such as hypoalbuminemia after surgery with a greater decrease in postoperative albumin (22). Although preoperative albumin is associated with an increased incidence of postoperative complications, the precise complications and the mechanisms involved remain unclear and warrant further research.
Operation-related findings: operation time and surgical approach
Studies have shown that operation time is related to the rate of postoperative incision infections after spinal surgery (23,24). Furthermore, intraoperative blood loss, surgical trauma, and duration of anesthesia are risk factors of postoperative complications (24-26). In this current study, operation time, which can be used to reflect intraoperative blood loss, surgical trauma, and duration of anesthesia, was shown to be an independent risk factor of overall postoperative complications. The average operation time of patients who presented with postoperative complications was 212.21±56.11 minutes compared to 169.93±46.26 minutes in patients who did not experience postoperative complications (P<0.001). Analysis using the ROC curve determined that operation time of 181 minutes was the diagnostic threshold for the occurrence of postoperative complications. In a study addressing the risk of spinal infections, Beiner et al. suggested that an operation time longer than 180 minutes predisposes the patients to postoperative infections, and antibiotics should be administered when surgery lasts longer than 180 minutes (27). The results of the latter study concur with our data and, taken together, suggest that controlled operation time within 180 minutes can reduce the risk of postoperative incision infections and the risk of overall postoperative complications. Therefore, optimizing operation time in STB patients to 180 minutes or less may be a crucial step in minimizing postoperative complications.
The anterior and posterior surgical approaches are commonly used in STB focus debridement. Our study indicated that using the anterior approach is an independent risk factor of postoperative complications, while the posterior approach is not a risk factor. Interestingly, the anterior approach is superior to the posterior approach regarding operative time, intraoperative bleeding, and correction of the Cobb angle (28,29). Furthermore, the anterior approach can achieve adequate debridement, better decompression, less muscle injury, and better interbody fusion cage placement. However, it cannot provide a satisfactory orthopedic result, causes more serious postoperative pain, and results in more complications related to the chest and abdomen due to the surgical channel (30). The risk of postoperative intestinal obstruction is 7.0% in anterior lumbar spinal surgeries (29).
On the contrary, the posterior surgical approach has the advantages of better implant fixation and better kyphosis correction. However, it is associated with insufficient nerve decompression and lesion removal, increased intraoperative bleed, and longer operative times (29). In summary, the anterior approach has better decompression effects but increased risk of postoperative complications, while the posterior approach has better orthopedic effects and fewer postoperative complications.
Scoring scale
STB patients have poor immunity, severe surgical trauma, and a high risk of postoperative complications (6,25,31). The development of a scoring scale to predict postoperative complications after STB debridement surgery is vital for the perioperative management of patients and can effectively help physicians decide on postoperative treatment strategies. This study is the first to quantify the risk of postoperative complications in spinal tuberculosis to the best of our knowledge. However, there were some limitations to the development of the scoring scale. Due to the small sample size of the validation set, the diagnostic accuracy of the scale cannot be fully validated. As the scale's sensitivity was not high, there may be a significant rate of missed diagnosis. In addition, there may have been other independent clinical risk factors that were not included in the present study. Further studies are warranted to confirm the validity and improve upon the scoring scale for risk assessment of postoperative complications in patients with STB.
Conclusions
This investigation identified five independent risk factors for postoperative complications in patients with STB, which were subsequently used to develop a scoring scale. A score of more than 4 points is considered to be associated with postoperative complications with high sensitivity and specificity. This scale is mainly dependent on clinical data, which is suitable for doctors to predict the changes in a patient's postoperative condition.
Study limitations
There were some limitations in this investigation. First, there may be some risk factors we didn’t take into inclusion. Second, the risk factors for different levels of postoperative complications were not investigated (32). Third, the sample size of the validation set was small. Future studies addressing these issues will be required to confirm these results.
Acknowledgments
Funding: This study was supported by the Natural Science Foundation of Chongqing (Grant Number: cstc2019jcyj-msxmX0358).
Footnote
Reporting Checklist: The authors have completed the TRIPOD reporting checklist. Available at https://dx.doi.org/10.21037/apm-21-851
Data Sharing Statement: Available at https://dx.doi.org/10.21037/apm-21-851
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/apm-21-851). The authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki (as revised in 2013) and was approved by the Institutional Ethics Board of The First Affiliated Hospital of Chongqing Medical University (No. ChiCTR1800019109). All participants provided written informed consent to participate in this study.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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