RECOSAN: Registry of Spinal Surgeries of Santiago, Multicenter and Prospective Study, First Report

Abstract

Objective The objective of this study was to describe the frequency statistics of spinal surgeries and factors associated with postoperative complications in Santiago de Chile. Material and methods, a prospective, multicenter standardized data registry of spine surgeries in Santiago was carried out from September 2020 to October 2021, the RedCap database (Vanderbilt University, v11.0.3) was used, patients of all ages who underwent spinal surgery were included as inclusion criteria, and patients who refused to participate in the study and spinal infiltrations were entered as exclusion criteria. The statistical analysis was developed using the SPSS v26.0 program and associations between variables were made.

Results An association was found between ASA I patients compared to ASA II-V patients regarding postoperative complications at 30 days with an OR 1.71 (95% CI 1.05-2.78), p = 0.029, an association was found between preoperative morbid history and complications at 30 days, OR 1.69 (95% CI 1.08-2.66), p = 0.021.

Discussion This is the first prospective multicenter registry of data on spinal surgeries in Santiago, containing detailed and standardized demographic and clinical information on all surgeries. A strong association was found between ASA II-V patients and postoperative complications at 30 days, as well as a direct association between preoperative morbid history and complications at 30 days.

Conclusions This first report with 832 spinal surgeries gives us valuable information on the patterns of spinal surgery in Chile, we hope to improve the number and quality of data collection in later reports, there could be a sub-registration of data on postoperative complications compared to data published in the literature.

Keywords

database - surgery record - spine surgery

Introduction

Databases provide easy access to large numbers of patients over large geographic areas.[1] There is growing interest in the use of databases in clinical research. Data is routinely collected during clinical visits, in hospitals, laboratories and/or pharmacies for administrative purposes.

Although initially these databases were designed for economic administration purposes and to reduce differences between health services, they are increasingly used for epidemiological research, treatments, complications and patient monitoring.[2]

The primary goal of spine surgery is to improve the patient's quality of life, restore function, and relieve pain[3]

Databases are extremely useful to stratify the severity of the disease and formulate a therapeutic and follow-up plan.

For the above, a careful planning process must be followed, ensuring the security and privacy of the information of participating patients.[4]

The registry in the form of a database gives the possibility of selecting the parameters to be recorded depending on the objective and organizing the collected information for subsequent evaluation and analysis.[7]

Data registration is typically conducted independently at each center, preventing the establishment of a regional understanding of the characteristics of the operated patients.[5]

The Santiago Spine Surgery Registry (RECOSAN) project emerged in 2015 from the interest of the members of the Spine Committee of the Chilean Society of Orthopedics and Traumatology (SCHOT) to record the regional experience of spine surgeons for subsequent analysis, statistics gathering, and conclusions.

The main author of the study (general coordinator) together with the President of the SCHOT Spine Committee of the year 2019 and spinal traumatologists representing 9 centers in Santiago (“local” coordinators) took this initiative, using an electronic database in order to obtain heterogeneous information and data in different centers.

The RECOSAN project is the first registry in Chile for information on spine surgeries, encompassing private clinics, public system hospitals, and military hospitals. This inclusion enables the analysis of the local reality.

Material and Methods

This work corresponds to an observational, longitudinal, prospective and multicenter study of spine surgeries in Santiago. Nine centers participate in the study, including Clínica Las Condes, Clínica Alemana, Instituto Traumatológico, Hospital Dipreca, Hospital Sotero del Rio, Clínica Meds, Clínica Red Salud Santiago, Clínica Red Salud Vitacura and Clínica Red Salud Providencia. For the registry, the RedCap database (Vanderbilt University, v11.0.3) was used in an anonymized manner. This first report included the data entered between September 2020 and October 2021. In each center, approval from the ethics committee was obtained and of the corresponding medical director, in addition to approval of the health services of the western and eastern areas (resolution No. 38 of 01/10/2018).

As inclusion criteria, patients of all ages, children and adults, all patients operated on for spinal pathology in the participating centers, were included. Biopsies and cultures were included. The exclusion criteria were patients who refused to participate in the study and spinal infiltrations.

The registry data included demographic variables, hospital center, medical-surgical history, specific diagnosis, surgical time, intraoperative bleeding, intraoperative complications, days of hospitalization, and postoperative complications at 1-month follow-up.

The statistical analysis was developed using the SPSS v26.0 program, through frequency analysis for qualitative and quantitative variables with 95% CI, chi-square test was used for analysis of variables between postoperative complications and ASA stage, as well as patient's previous comorbidities, statistical significance was set at a P value <0.05.

Results

The data registry began on September 1, 2020, and continued until the present date, October 1, 2021. Nine centers in Santiago participated, including private clinics, public hospitals, and military hospitals. A total of 832 patients were entered into the registry, with contributions from 37 spinal surgeons from different centers.

Of the 832 surgeries recorded, 48.4% were men (n = 398), 51.6% were women (n = 424) and an average age at the time of surgery was 51.3 (SD 19.5) ([table 1]). 48.3% had a reported medical history.

Table 1

Gender	Frequency (n)	Percentage (%)
Female	424	51,6
Male	398	48,4
Total	832	100

22.2% (n = 184) of the patients had previous spine surgeries ([table 2]) and of these, 61.2% (n = 112) were in the same segment, 27.3% (n = 50) were in adjacent segment and 11.5% (n = 21) were in other segments ([table 3]). Of all previous spine surgeries, 47.5% (n = 87) were arthrodesis as shown in [table 4].

Table 2

Previous surgery	Frequency (n)	Percentage (%)
No	648	77,80
Si	184	22,20
Total	832	100

Table 3

Location of previous surgery	Frequency (n)	Percentage (%)	Cumulative frequency (N)	Cumulative percentage (%)
In another segment	21	11,50	21	11,50
Same segment	112	61,20	133	72,7
Adjacent segment	50	27,30	183	100,00
Total	183	100	183	100

Table 4

Type of previous surgery	Frequency (n)	Percentage (%)	Cumulative frequency (N)	Cumulative percentage (%)
Arthrodesis	87	47,54	87	47,54
Decompression	29	15,84	116	63,38
Discectomy	67	36,62	183	100
Total	183	100	183	100

Regarding the type of spinal pathology, 69.9% (n = 582) were degenerative, 10.09% (n = 84) traumatic, 8.89% (n = 74) deformities, 8.89% (n= 74) tumor pathology and 2.16% (n = 18) infectious ([tabla 5]).

Table 5

Type of pathology	Frequency (n)	Percentage (%)	Cumulative frequency (N)	Cumulative percentage (%)
Deformity	74	8,89	74	8,89
Degenerative	582	69,95	656	78,84
Infectious	18	2,16	674	81,01
Trauma	84	10,09	758	91.1
Tumor	74	8,89	832	100
Total	832	100	832	100

The most frequent diagnosis was hernia of the nucleus pulposus (HNP) 32.3% (n = 269), followed by degenerative stenosis 16.8% (n = 140), acute fracture 7.57% (n = 63), degenerative spondylolisthesis 5.5% (n = 46), idiopathic scoliosis 5.5% (n = 46) see[ table 6].

Table 6

Main diagnostic	Frequency (n)	Percentage (%)	Cumulative frequency (N)	Cumulative percentage (%)
Primary HNP*	269	32,33	269	32,33
Degenerative stenosis	140	16,82	409	49,15
Acute fracture	63	7,57	472	56,72
Idiopathic scoliosis	46	5,53	518	62,25
Degenerative spondylolisthesis	46	5,53	564	67,78
Recurrent HNP*	39	4,68	603	72,46
Metastasis	36	4,32	639	76,78
Pathological bone fracture	35	4,20	674	80,98
Transitional syndrome	21	2,52	695	83,50
Discogenic pain/severe discopathy	16	1,92	711	85,42
Pyogenic spondylodiscitis	12	1,44	723	86,86
Other scoliosis	10	1,20	733	88,06
Degenerative scoliosis	9	1,08	742	89,14
Low-grade lytic spondylolisthesis	7	0,84	749	89,98
Primary bone tumor	7	0,84	756	90,82
TB Spondylodiscitis	4	0,48	760	91,31
Scheuermann's disease	3	0,36	763	91,67
Congenital stenorrhachis	3	0,36	766	92,03
Other	66	7,94	831	100
Total	832	100	831	100

Regarding the type of surgery, discectomy was the most common type of surgery in 423 surgeries, of which 62% (n = 263) were discectomy for lumbar HNP. In second place as a surgical technique is instrumented arthrodesis in 454 surgeries ([table 7]). Of these, 267 were in the lumbar region. Interbody fusion technique was used in 44% of lumbar arthrodesis (most with TLIF technique, in 115 cases).

Table 7

Column fixation	Frequency (n)	Percentage (%)
No	378	45,43
Yes	454	54,57
Total	832	100,00

The most frequent approach was the posterior 72.7% (n = 330), followed by the anterior 23.8% (n = 108) and the combined anterior plus posterior technique occurred in 3.5% (n= 16), see[ table 8].

Table 8

Approach	Frequency (n)	Percentage (%)
Anterior	108	23,79
Combined	16	3,52
Posterior	330	72,69
Total	454	100,00

In the preoperative evaluation, 54% of the patients were classified as ASA II. 14.5% (n = 120) of the surgeries were performed on an outpatient basis and 85.5% (n = 712) were hospitalized.

The type of surgery most frequently performed was with open technique with 642 cases, percutaneous with 93 cases, tube with 66 cases and endoscopic technique with 45 cases.

Surgical times and bleeding averages for all pathologies were recorded. [Table 9] shows the data mentioned for the 5 most frequent pathologies.

Table 9

Pathology	Frequency (n)	Surgical duration (minutes)	Operative bleeding (ml)
Primary Lumbar HNP	269	86,4	35,5
Degenerative Lumbar Stenosis	140	195,8	283,8
Acute fracture	63	115,8	233,8
Degenerative spondylolisthesis	46	197,2	309,8
Idiopathic scoliosis	46	315,7	555,7

The days of hospitalization for pathologies were recorded. It was observed that the shortest hospitalization time was for discectomy due to lumbar PPH with an average of 1.6 days and the longest hospitalization time for spinal cord trauma was 22.5 days, and spondylodiscitis due to TB was 21.8 days ([graph 1]).

Graph 1 Average number of days of hospitalization according to main diagnosis. *HNP: Hernia of nucleus pulposus; **TRM: Spinal cord trauma; ***TBC: tuberculosis

Intraoperative complications occurred in 2.9% (n = 16) of cases ([graph 2]). Postoperative complications within the first month were recorded in 11.7% (n = 90), dividing them into medical complications and surgical complications ([graph 3] and [4]). An association was found between patients categorized as ASA I compared to patients categorized as ASA II to V regarding postoperative complications at 30 days with an OR 1.71 (95% CI 1.05-2.78) with p value = 0.029, and also an association was found between preoperative morbid history and 30-day postoperative complications with an OR 1.69 (95% CI 1.08-2.66) with p value = 0.021.

Graph 2 Number of intraoperative complications.

Graph 3 Number of medical complications in the first postoperative month.

Graph 4 Number of surgical complications in the first postoperative month.

Discussion

According to Solomon, a data registry is defined as a systematic collection of a clearly defined set of demographic and clinical data on patients with specific health or treatment characteristics, which is maintained in a central database for a predefined purpose.[5] Data registries in spinal surgery offer certain advantages over Randomized Clinical Trials (RCTs), and there is strong justification for conducting spinal registries. Among these justifications are the high demands they address, despite utilizing very limited healthcare system resources compared to randomized clinical studies, including the rising healthcare costs. The increasing number of spinal implants serves as another rationale for establishing registries, along with various innovations in spinal surgery that have been recently introduced or will be in the future. With multiple surgical treatment options, a heterogeneous and increasingly aging patient population, often lacking consensus in the management of certain spinal pathologies, and varying surgeon preferences, registries prove valuable[6].

There are many parties interested in the development of adequate data registries in spine surgery, there are patients and doctors seeking to improve the quality of care, there are administrators seeking to create new health policies, there are researchers with the aim of generating and disseminating new evidence, there is the industry that is interested in costs, profits, competition, and profitability.

To the best of our knowledge, this is the first prospective multicenter registry of spinal surgery data in Santiago, with standardized demographic and clinical information for all spinal surgeries. The distribution of surgeries by gender was similar, with 48.4% being male and 51.6% female. 70% of the surgeries were performed for degenerative conditions, a figure that may continue to rise due to the increasing aging of the population. Surgery for herniated nucleus pulposus (HNP) is the most frequent procedure, accounting for 32.3%, followed by degenerative stenosis (16.8%), and fractures (7.5%).

Consistent with the most frequent surgeries performed for HNP and lumbar stenorachis, the surgical techniques of discectomy are in first place with 50.8%, and instrumented arthrodesis with 47%, the lumbar area is the most frequently operated segment, 44%, and the most used arthrodesis technique is the transforaminal approach (TLIF).

Endoscopic surgery still occupies a very small place with 45 cases compared to the open technique with 642 cases and tube surgery with 66 cases, data that agree with the little development of the endoscopic technique in spine surgery in Latin America.

The overall average hospitalization time was 4.7 days, and the pathologies that presented the longest hospitalization times were pyogenic spondylodiscitis with 20.3 days, TB spondylitis with 21.8 days, and spinal cord trauma with 22.5 days.

Intraoperative complications occurred in 1.9% of the cases, while postoperative complications within the one-month follow-up period were observed in 11.7% of cases. When compared to values reported in the literature, these percentages are significantly lower, which leads us to believe that there was inadequate recording of complications by the surgeons.

We sought an association between ASA classification II to V and complications within the first postoperative period using a chi-square test and found an OR of 1.71 (95% CI, 1.08-2.66) with p = 0.029. Similarly, we examined the association between comorbidities and complications within the first postoperative month, resulting in an OR of 1.69 (95% CI, 1.08-2.66) with p = 0.021. Both associations are statistically significant, indicating that ASA classification II or higher and a greater number of complications directly influence the likelihood of developing postoperative complications within the first month. This association will be further evaluated based on specific surgeries and specific pathologies, and a more comprehensive analysis will be possible with a larger number of cases in future data registry reports.

Conclusions

This is the first report of a new multicenter, prospective spine surgery data registry, with standardized demographic and clinical data. We hope that over time many more centers will be included in the registry in order to have more detailed information in accordance with the reality of our country. This first report with 832 patients already provides us with valuable information about the behavior of spine surgery in Chile. We hope that in subsequent reports we can do a more detailed analysis by subgroups, according to pathology, the type of surgery and the specific complications in each group. The study highlights a potential underreporting of intraoperative and postoperative complications when comparing the data to figures published in the literature. This underreporting may be influenced by each surgeon's perception of even minor complications. To address this issue, we propose the creation of new variables for possible complications associated with each type of pathology, which could facilitate and guide the data recording process. An association was found between morbid history and ASA II classification or higher with the presentation of postoperative complications in the first month with statistically significant values. In future data registry reports, we intend to explore additional associations based on diagnosis, specific pathologies, and hospitalization durations. This effort aims to support the development of new research projects.

Conflict of Interest

None.

• Bibliografía

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Publication History

Received: 12 July 2022

Accepted: 22 August 2023

Article published online:
30 October 2023