Soft-tissue sarcomas are malignancies that originate from mesenchymal cells. These rare tumors represented 0.7% of all cancers diagnosed in the United States in 2022.1 Soft-tissue sarcomas typically present with nonspecific symptoms such as a growing painless mass, whereas systemic symptoms such as fever or weight loss are rare.2 In addition, the prevalence of benign soft-tissue tumors vastly exceeds that of sarcomas, which, when combined with their ambiguous presentation, can result in frequent unplanned excisions in the community setting.3,4 Noria et al5 described the term “unplanned excisions” in the context of soft-tissue sarcomas that were resected without the proper preoperative diagnostic modalities and without the intention to achieve tumor-free margins.

The treatment cornerstone for soft-tissue sarcomas is wide-margin excision of the lesion.6 Surgical procedures performed without such intent and thoughtful planning in the context of unawareness about the underlying malignant diagnosis frequently increase the likelihood of residual tumor and local recurrence.5,7 Unplanned excisions tend to occur in a community or nonspecialized sarcoma center setting, where this rare disease is seldom diagnosed or treated.8 Once the unplanned excision has been performed and the sarcoma diagnosis rendered, the patient ought to be referred for definitive care to a center with experience in malignant soft-tissue tumors. The referred sarcoma specialist, typically an orthopaedic oncologist, and accompanying multidisciplinary team then decide the optimal treatment course. Re-excision of the tumor bed and any residual tumor commonly involves more morbid surgery, sometimes necessitating flap coverage and radiation therapy, leading to additional costs to the patient and the healthcare system.9

The purpose of this study was to analyze the incidence of unplanned sarcoma excisions performed by orthopaedic surgeons and to determine why these continue to occur across all medical specialties.

Methods

A retrospective case-control study was conducted using data from patients who received care at our institution between January 2013 and July 2017. A total of 457 charts were reviewed. The population consisted of pediatric and adult patients with soft-tissue sarcoma of the extremities or pelvis. Exclusion criteria included incomplete chart information and a follow-up period shorter than 6 months. Two separate samples were identified, one including patients who underwent an unplanned excision before seeking care at our institution (n = 107) and a second sample consisting of patients whose entire care was performed at our specialized sarcoma center, including the planned excision (n = 102). The patient's initial symptoms, imaging studies performed before excision, initial pathology diagnosis, referring center, and specialty of the referring physician were recorded. A root cause analysis (RCA) was conducted with all the unplanned procedures using outside records to identify the preventable causes that led to the undesirable outcome.

Statistical Analysis

Incidence of unplanned excisions and its related complications were calculated using general descriptive statistics. Possible associations between variables were assessed using either chi square test or Fisher exact test for categorical variables and Kruskal-Wallis test for continuous variables. Statistical analyses were conducted using SPSS version 18.0 software (IBM). All tests were deemed significant if P was <0.05.

Source of Founding

No funding was received for this project.

Results

For statistical analysis, 107 patients with unplanned procedures were included (Table 1). The most common healthcare settings for unplanned excisions were local community centers and private practices (83.2%, n = 89). For the studied sample (n = 457), the incidence of unplanned excisions encountered during the analyzed period was 23.4% (n = 107) (Figure 1). The median tumor size was 6 cm, and the mean tumor size was 7.2 cm (range 1 to 22, SD 4.4). Most of the patients presented to the initial consultation with a chief report of a growing mass (43.0%, n = 46) or painless mass (30.8%, n = 33). The most common initially presumed were lipoma (24.3%, n = 26) and cyst (18.7%, n = 20). Inadequate imaging, defined as not obtaining an MRI with and without contrast, was encountered in 76.6% of the patients (n = 82, 95% confidence interval, 67.8 to 83.6). Forty-five patients (42.1%) had no imaging studies at all preoperatively (Table 2). Forty patients obtained an MRI before surgery; 25 among them had the study performed with and without contrast. The possibility of sarcoma or malignant diagnosis was mentioned in 45.0% (n = 18) of the reports. Most commonly cited misdiagnoses were nonspecific benign mass (30.0%, n = 12) and hematoma (17.5%, n = 7). Fifteen patients had an ultrasonography preoperatively; two reports mentioned sarcoma or malignancy in the differentials. The most common incorrect diagnoses in ultrasonography reports were nonspecific benign mass (33.3%, n = 5) and hematoma (20.0%, n = 3). Fourteen patients had a CT scan; five had intravenous contrast. Four CT scan reports (28.6%) mentioned sarcoma or malignancy. Seventy patients had a tumor bigger than 5 cm. Among those, 11.4% (n = 8) had a biopsy preoperatively. One-fourth (n = 2) of the pathology reports mentioned sarcoma.

Table 1 - Patient and Tumor Characteristics Patient and Tumor Characteristics Age (yr) 59 (12-87, SD 17.7) Sex  Male 59 (55.1%)  Female 48 (44.9%) Location  Upper extremity 43 (40.2%)  Lower extremity 54 (50.5%)  Pelvis 10 (9.3%) Initial presentation  Growing mass 46 (43.0%)  Painless mass 33 (30.8%)  Painful mass 17 (15.9%)  Skin lesion 11 (10.3%) Misdiagnoses  Lipoma 26 (24.3%)  Cyst 20 (18.7%)  Ulcer 7 (6.5%)  Hematoma/vascular lesion 5 (4.7%)  Lymph node 4 (3.7%)  Melanoma/mole 3 (2.8%)  Abscess 3 (2.8%)  Other benign lesions 39 (36.4%)  Mean symptom duration (wk) 22 (1-96, SD 21.1) Medical specialty  General surgery 50 (46.7%)  Orthopaedic surgery 19 (17.8%)  Dermatology 17 (15.9%)  Podiatry 6 (5.6%)  Plastic surgery 3 (2.8%)  Other 12 (11.2%)
Figure 1:

Strobe flow diagram of the selection of the study sample.

Table 2 - Imaging Studies Imaging Study Total (n, %) Correct Report (n, %) MRI 40 (37.4%) 18 (45.0%)  With contrast 25 (23.4%) 14 (56.0%)  Without contrast 15 (14.0%) 4 (26.7%) US 15 (14.0%) 2 (13.3%) CT 14 (13.1%) 4 (28.6%) No studies 45 (42.1%) N/A
Orthopaedic Surgeons

Orthopaedic surgeons were the second highest specialty to perform unplanned excisions (17.8%, n = 19). General surgeons were involved in most of the unplanned excisions (46.7%, n = 50) (Table 1). Most of the patients who sought care at an orthopaedic service presented initially with a growing mass (43.8%, n = 7) or painless mass (43.8%, n = 7). Twelve patients cared by orthopaedic surgeons had tumors that were larger than 5 cm; in 25% of these larger sarcomas (n = 3), a biopsy was attempted. Fourteen of the unplanned excisions (73.7%) involved a tumor located deeper into the fascia layer, compared with the overall sample (55.1%). This difference was not notable. Orthopaedic surgeons obtained an MRI with contrast before the excision in 47.3% (n = 9) of cases, compared with 18.2% (n = 16) of other medical specialty services (P = 0.013). Orthopaedic surgeons were more likely to request a biopsy (25.0%) compared with other medical specialties (8.6%); however, this difference was not statistically significant. In addition, orthopaedic surgeons did not perform any transverse incisions.

Root Cause Analysis

A RCA of all the unplanned procedures was conducted by analyzing outside records. An Ishikawa diagram was used as a problem-solving quality tool (Figure 2). The first challenge encountered was the incorrect presumption of a diagnosis without additional investigation (45.8%). The physician erred toward a benign diagnosis, electing to operate without ancillary examinations. In the subsequent stage, 76.6% of the patients did not have an MRI with and without contrast. For those patients who had imaging preoperatively, 67.6% had an incorrect report. In 70 cases (65.4%), the tumor was larger than 5 cm; only eight of these patients had an attempted biopsy. Those were incorrectly reported as benign or had an inconclusive diagnosis in six of the eight sarcomas. When conducting a RCA specifically for orthopaedic surgeons, the errors or events that led to the ultimate undesirable outcome, the unplanned excision, are the same compared with those of the whole sample, with differences in incidence. The first event encountered in the RCA, a physician who assumes a benign diagnosis before obtaining any ancillary examinations, was more frequent among orthopedic surgeons (n=11, 57.9%) when compared to other physicians (n=38, 43.2%); this higher rate compared with the remaining sample was not statistically significant. Furthermore, as previously mentioned, orthopaedic surgeons were more likely to order an MRI with and without contrast (47.3%, n = 9 versus 18.2%, n = 16) and more likely to order a biopsy when indicated for tumors larger than 5 cm (25.0%, n = 3 versus 8.6%, n = 5), only the former being statistically significant.

Figure 2:

Root cause analysis Ishikawa diagram. Ishikawa diagram demonstrating all encountered obstacles along the time line that led to the unplanned excisions in the overall sample.

Complications

Seven patients (6.5%) in the unplanned excision group had a transverse incision, 4 (3.7%) had a circumferential one, and the remaining patients (89.7%) had a longitudinal approach. After referral, 6 patients (5.6%) required an amputation and 92 patients (86.0%) underwent tumor bed re-excision. For the remaining patients, the tumor was considered unresectable (3.7%, n = 4) or observation (4.7%, n = 5) was indicated. Positive margins were reported in the initial unplanned procedure in 78 patients (72.9%) ,and 20 patients had close margins (<1 mm) (18.7%); these patients underwent a second procedure. For the patients who underwent a second surgery (n = 98), primary closure was feasible in 67 patients (68.4%). For the remaining patients, 18 (18.4%) required a flap, 9 (9.2%) had negative wound pressure therapy applied followed by a second-stage flap, and 4 (4.1%) required negative pressure dressing therapy. Postoperative wound complications for the unplanned excision procedure included infection (10.3%, n = 11), dehiscence (20.6%, n = 22), or a combination of both (17.8%, n = 19). Twenty-two patients (22.4%) required an additional surgical intervention because of wound complications. In the re-excision procedure, 30 patients (30.6%) had positive margins. Twenty patients (18.7%) with tumors smaller than 5 cm required adjuvant radiation therapy because of the unplanned initial surgery.

The complications from the unplanned excisions were then compared with the control group (n = 102) (Table 3). Patients with unplanned excisions were more likely to have smaller sarcomas (P < 0.001) and subcutaneous tumors (P = 0.002). Unplanned excisions were associated with significantly higher risk of dehiscence or dehiscence with infection (P < 0.001). Patients with unplanned excisions were also significantly more likely to require amputation (P = 0.029). Planned excisions (control group) had a significantly lower rate of positive margins (P < 0.001) (Table 3). No significant statistical differences were observed regarding age and sex among the unplanned excision group and control group.

Table 3 - Unplanned Excision and Planned Excision Group Comparison Covariate Statistics Level Group P a Control N = 102 Unplanned Excision N = 107 Age N (%) — 59 (21-94, SD 16.8) 59 (12-87, SD 17.7) 1.0 Sex N (%) Female 53 (51.96) 48 (44.86) 0.33 N (%) Male 49 (48.04) 59 (55.14) Location N (%) UE 31 (30.39) 43 (40.19) 0.037 N (%) LE 49 (48.04) 54 (50.47) N (%) Pelvis 22 (21.57) 10 (9.34) Wound complicationsa N (%) Infection 19 (18.63) 11 (10.28) <0.001 N (%) Dehiscence 10 (9.8) 22 (20.56) N (%) Both 4 (3.92) 19 (17.75) N (%) No 69 (67.65) 55 (51.4) Dehiscence N (%) No 88 (86.27) 66 (61.68) <0.001 N (%) Yes 14 (13.72) 41 (38.32) Amputation N (%) No 102 (100) 101 (94.39) 0.029 N (%) Yes 0 (0) 6 (5.61) Planned excision vs unplanned excision first surgery positive margins N (%) Negative 87 (85.3) 29 (27.1) <0.001 N (%) Positive 15 (14.7) 78 (72.9) Planned excision (N = 23) vs unplanned excision (N = 98) second surgery positive margins N (%) Negative 19 (82.6) 68 (69.4) 0.20 N (%) Positive 4 (17.4) 30 (10.6) Depth N (%) Deep 77 (75.49) 59 (55.14) 0.002 N (%) Subcutaneous 25 (24.51) 48 (44.86) Size N 101 107 <0.001 Mean 11.34 7.16 Median 10 6 Min 1 1 Max 38 22 SD 6.44 4.38

LE = lower extremity, UE = upper extremity

aThe P-value for categorical variables is either for chi square test or Fisher exact test as appropriate. The P-value for the continuous variables is for Kruskal-Wallis test. Bold represents statistically significant data.

Discussion

Unplanned excisions of soft-tissue sarcomas continue to be a frequent and unfortunate occurrence. The incidence of unplanned procedures observed (23.4%, n = 107 of 457) was comparable with the literature.7,10–12 The referred team is frequently confronted with an uncertain context in which potentially difficult decisions must be made based on limited and unreliable information. Previous studies have shown a high rate of histologic diagnostic discrepancy between referring centers and sarcoma facilities.13 In addition, preceding data have demonstrated no relationship between preoperative information and likelihood of residual tumor after unplanned procedures.5,14 Unplanned excisions frequently result in additional morbid procedures, the requirement for additional therapy, increasing costs to the patient and the system, and a negative effect on prognosis.9,15–18 Similarly, unplanned excisions have an increased likelihood of positive margins, as did the patients in our sample, and prior studies have shown that even when margins are read as negative, residual tumor is often found on the re-excision specimen.12 Owing to the wider re-excision area necessary after an unplanned procedure, patients may require a previously unnecessary flap had the tumor been initially resected in accordance with oncologic principles. Moreover, because of more extensively required re-excision, wound complications are more frequent.9 Patients in our control group had a higher percentage of wound infections than those in the unplanned procedure group (19% versus 11%); this unusual difference could be explained by the fact that the control group had larger masses, more deep and more pelvic tumors, as well as the fact that those patients when seen before resection in a sarcoma center may have radiation therapy indicated preoperatively (n = 18). Radiation therapy is indicated in high-grade sarcomas larger than 5 cm to reduce the likelihood of local recurrences.19 However, after an unplanned excision, the indication might be extended to smaller tumors given the increased probability of residual disease.15,20

Our study sheds light on the role that orthopaedic surgeons continue to play in the overall burden of unplanned excisions. A prior study analyzing unplanned excisions published in 2009 showed that 20.3% of these procedures were caused by orthopaedic surgeons.21 Unfortunately, our analysis demonstrates this percentage to remain similar many years later. This information may come as a surprise to some, given that according to the Accredited Council of Graduate Medical Education, oncology orthopaedic surgery is part of the didactic curriculum of all orthopaedic residency programs.22 Furthermore, clinical experience and patient exposure must comprise oncology orthopaedic cases in all accredited residencies.22 However, the recommended minimum number of case exposure per resident is 10, comprising all the oncology orthopaedic spectrum, which may lead to residents never encountering a soft-tissue sarcoma throughout residency.23 The Musculoskeletal Tumor Society, a recognized authority in orthopaedic oncology, issued in 2017 guidelines urging the prompt referral of any patient with a mass larger than 5 cm to a physician with the appropriate training, a sarcoma specialist.24 In addition, there is an increased number of scientific literature dedicated to the matter of unplanned sarcoma excisions and alerting about its consequences. Additional studies are needed to assess the effect of recent recommendations and guidelines on the rate of unplanned excisions and to potentially endorse more intense education efforts toward the orthopaedic community and during orthopaedic training. Previous studies have observed that other surgical specialties continue to perform a much higher number of soft-tissue excisions than orthopaedic oncologists or surgical oncologists.25 Soft-tissue excisions almost always constitute elective procedures; therefore, there should be no impediment for an appropriate workup and timely referral to a specialized center.

In a RCA, typically, multiple underlying causes are identified rather than a single triggering event. An Ishikawa26 diagram (Figure 2) is a cause-and-effect map that facilitates the visualization of obstacles along a time line. In our analysis, the most notable obstacles found were (1) assumption of a benign diagnosis, (2) failure to obtain the appropriate imaging study, (3) incorrectly reported imaging studies, (4) failure to order a biopsy, and (5) incorrect biopsy reporting. These challenges could be alleviated by increasing awareness. Moreover, all errors found are entirely preventable with prompt referral. Several recent studies support this recommendation, demonstrating that patients cared at specialized sarcoma centers have decreased rates of positive margins, better local control, and improved overall survival.27–29

Our RCA indicated that multiple incidents, independently or sequentially, contributed to the undesirable outcome. The initial incident was diagnostic misassumption, erring toward a benign diagnosis. This occurred in 45.8% (n = 49) of unplanned excision cases, being more frequent among orthopaedic surgeons (57.9%, n = 11). Different factors contributed to this misassumption. Non-malignant tumors and other conditions, such as inflammation or infection, are far more prevalent.3 The symptoms and physical findings of soft-tissue sarcomas are nonspecific. Oftentimes, patients tend to relate a new mass with a history of trauma, even if remote. Hematomas outside the setting of anticoagulant therapy, blood dyscrasias, or iatrogenic causes, are uncommon.30 The accepted standard for the assessment of soft-tissue tumors is an MRI with and without contrast.31–33 Nonetheless, 76.6% (n = 82) of the patients in the unplanned excision sample did not have the appropriate examination to assess their tumor. More concerning, 42.1% (n = 45) of patients did not have any imaging study preoperatively. Orthopaedic surgeons performed better than other specialties in our sample analysis, demonstrating a higher likelihood of ordering the appropriate study (47.3% versus 18.2%). It is worth mentioning that occasionally, providers, although cognizant about the need for imaging studies, are precluded from obtaining the examinations because of insurance restrictions. In 67.6% of cases involving patients who had imaging studies before surgery, the diagnosis reported was incorrect or inconclusive. This could represent a confirmation bias for the ordering physician believing the diagnosis is benign and providing that as the reason for ordering the study, which subsequently may bias the radiologist. MRI studies performed outside a specialized sarcoma center frequently omit pertinent sequences and generate inconclusive reports.34 Moreover, erring toward a benign condition in the radiologic diagnosis may explain the high percentage of positive margins in the unplanned procedures (72.9%) and the additional patients who underwent re-excision because of close margins (18.7%, n = 20). This relevant finding of our RCA emphasizes the importance for the orthopaedic surgeon of maintaining a high level of suspicion, especially for masses larger than 5 cm, and not simply rely on imaging reports that can be inaccurate in two of three cases. The European Society for Musculoskeletal Radiology created guidelines dedicated to imaging of soft-tissue tumors in an attempt to reduce the incidence of unplanned resections. These guidelines comprise recommended sequences to be obtained, as well as a series of findings that must be addressed in the report, including the need for referral to a sarcoma center and the need for a biopsy to better elucidate the diagnosis.34 A potential strategy to palliate this recurring scenario in our country could include the recommendation from the reporting radiologist to refer any nonspecific or concerning masses larger than 5 cm to a specialized sarcoma facility. In addition, previous studies have described determinate lesions on MRI (e.g., lipomas, hemangioma, and ganglion), meaning those that can be safely diagnosed with this imaging modality, eliminating the need for a biopsy, which the reporting radiologist should be familiar with.35 Continuing the RCA, the following incident is encountered at the failure to request a biopsy before excision. Tumors larger than 5 cm have an increased likelihood of being malignant; therefore, a biopsy is recommended before definitive surgery to avoid a “whoops procedure.”36–38 In such cases, a core needle biopsy is the appropriate first step rather than an open or excisional biopsy, unless performed by a trained oncologic surgeon. Among those tumors meeting criteria for a biopsy (n = 70 of 107), only 8 (11.4%) had the biopsy. Excisional biopsies have a role in diagnosing soft-tissue tumors when correctly indicated, for example, in the case of tumors smaller than 5 cm, when the mass is resected in one piece and with appropriate margins, or in case the tumor is a sarcoma. This encompasses a difficult scenario for the community physician or the non–oncology-trained orthopaedic surgeon. Small masses have a lower likelihood of being malignant, and there is a logistic impossibility of referring every small mass to a sarcoma center. Therefore, in such cases, an excisional biopsy could be indicated. However, it is paramount that oncologic principles are respected during the procedure, e.g., do not violate the tumor or do not remove the mass in pieces. Nevertheless, in our sample, no patient underwent the initial procedure with this intent as concluded by the outside records analysis. Six of the eight biopsies performed yielded an incorrect or inconclusive diagnosis consistent with the current literature indicating a high percentage of diagnostic error when biopsies are performed outside of a specialized center.13 This finding could be seen as forgiving for the surgeon performing the unplanned resection, given this physician did his or her best effort to arrive at an accurate diagnosis before resection, but was misled by an inaccurate histopathology report. Moreover, it can oftentimes be laborious to refer a patient with a biopsy-proven benign diagnosis to a specialized sarcoma center, thus finding the physician no other alternative than to proceed.

In addition, it is important to mention that oftentimes even with a malignant diagnosis, it can be challenging for some patients to be referred to a sarcoma center. In some instances, this can be because of insurance constraints and in others because of geographical distances from sarcoma reference centers that would imply patients leaving behind their support network and increased costs to the patient and family. In 2017, the Musculoskeletal Tumor Society performed a census of the oncology orthopaedic surgeons working in the United States, showing several states with none or merely one oncology orthopaedic surgeon practicing.39 Recently, some European countries have adopted the model of sarcoma networks, where patients must be referred from diagnosis to receive care at specially designated centers with proven sarcoma experience.27–29 An app was also recently designed to facilitate the referral pathway, shortening waiting times for patients.40

The limitations of our study include the retrospective nature of the analyses and obtaining data from secondary sources. In addition, this was a single-institution investigation, and some patients may have pursued treatment of their unplanned excisions elsewhere, leading to an underestimation of the unplanned excision incidence. Furthermore, we only have access to data of patients who were successfully referred, not accounting for those cases where the referral was unsuccessful or when the surgical procedure had a positive outcome in the community setting.

Conclusion

Despite educational efforts, unplanned excisions and their devastating consequences continue to occur, even among orthopaedic surgeons. The results of our RCA indicate that multiple incidents, occurring independently or sequentially at different stages of patient care, contributed to the adverse event. These various causes could be mitigated by increasing community awareness about soft-tissue sarcomas, and most importantly, they could be entirely avoided by timely referral of patients to a specialized sarcoma center. The findings of our study will hopefully increase awareness in our medical community.

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