Abstract
Background
The 5-factor frailty index (5-mFI), validated frailty index with Spearmen rho correlation of .95 and C statistic >.7 for predicting postoperative complications, can be preoperatively used to stratify patients prior to parastomal hernia repairs.
Methods
Retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database identified patients from 2015 to 2020. 5-mFI scores were calculated by adding one point for each comorbidity present: diabetes mellitus, congestive heart failure (CHF), hypertension requiring medication, severe chronic obstructive pulmonary disease (COPD), non-independent functional status. Primary endpoint was 30-day overall complications; secondary endpoints were 30-day readmission, reoperation, and discharge to care facility.
Results
2924 (52.2% female) patients underwent elective parastomal hernia repair. Univariate analysis showed 5-mFI
Conclusions
Parastomal hernia repair patients with 5-mFI score of
Keywords
Key Takeaways
• The 5-mFI score is a validated tool to identify ideal candidates for surgical intervention. • Our study found that parastomal hernia repair patients with a 5-mFI score of at least one, had a higher risk of renal, pulmonary, cardiovascular and hematologic complications, readmissions, discharge to care facility, and mortality. • The 5-mFI score can be a useful tool for surgeons during preoperative risk stratification.
Introduction
Some surgeons believe that parastomal hernias are an inevitable sequela of colostomy creation with an incidence rate of 30%–48%.1-4 Previous studies have found that the majority of parastomal hernias occur within 2 years of stoma creation, with the incidence of herniation increasing with time.1-8 Parastomal hernias are often asymptomatic and have no definitive guideline for determining when elective repairs should be offered.1,3 However, intractable pain, skin breakdown, and interference with the integrity of the stoma appliance seal are often cited as relative indications for surgical intervention.1,7,9 Options for repair broadly include laparoscopic and open primary suture repair, mesh-based repairs, or relocation of the stoma.1,6,9 Regardless of the methods used, these reconstructive operations carry a high risk of postoperative complications, with rates as high as 30%-76%.3,7,8,10 Potential complications from surgical repair of parastomal hernias include infection, postoperative pain, delayed bowel function, readmission, and reoperation.1,7,8
Given the overall cost and morbidity associated with complications of parastomal hernia repair, it is imperative that surgeons diligently risk-stratify patients and identify those who would benefit most from surgical repair. Previous studies have identified patient-related factors such as advanced age, increased intra-abdominal pressure, diabetes mellitus, obesity, and emphysema as poor prognosticators. 7 However, these proposed risk factors by themselves are limited in their ability to provide a standardized way to risk-stratify patients in the preoperative stage. 7
Recently, there has been growing evidence that frailty, the decrease in physiologic reserve against stressors, can be used preoperatively to quantify risk.11-15 Originally adapted from an 11-variable frailty index, the modified 5-factor frailty index (5-mFI) is a validated scoring system of frailty that has been proven to be a robust predictor of adverse outcomes. 16 Factors assessed in 5-mFI scoring include diabetes mellitus, newly diagnosed congestive heart failure (CHF) or exacerbation of existing CHF within 30 days of surgery, history of hypertension requiring medication, history of severe chronic obstructive pulmonary disease (COPD) and non-independent functional status.11,14,16-22
The 5-mFI score can become a beneficial tool for identifying ideal candidates for parastomal hernia repair, to reduce the cost and overall incidence of complications.11,16,23 The purpose of this study was to the assess 5-mFI score as a predictor of 30-day overall complications as well as 30-day readmission, reoperation, and need to discharge to a care facility (acute rehabilitation center and skilled nursing facility) in patients undergoing parastomal hernia repair.
Methods
Database and Patient Selection
A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was conducted to identify adult patients (
To identify patients who underwent parastomal hernia repair, a combination of International Classification of Diseases (ICD)-9 and ICD-10 diagnostic codes along with Current Procedural Terminology (CPT) codes were utilized. First, ICD-9 codes (569.60, 569.62, 569.69, 569.89) for “stomal hernia or prolapse” or ICD-10 codes (K43.3, K43.4, K43.5) for “parastomal hernia with or without obstruction and gangrene” were used to select cases that represent true parastomal hernias. Next, CPT codes (44346, 49560, 49561, 49565, 49566, 44238, 49652-49657, 49659) were used to identify patients who underwent hernia repair. Concurrent ventral hernia repair, relocation of stoma, and bowel resection (small and large bowel) were identified using additional CPT codes (Supplemental Table 1). All other types of hernia repairs were excluded from this study. The following information was collected for each included patient: sex, age, body mass index (BMI), smoking status, comorbidities, and 30-day postoperative outcomes.
Study Design
A 5-factor modified frailty index score (5-mFI) was calculated for each patient. The score was calculated by adding 1 point for the presence of each one of the following 5 comorbidities: (1) history of diabetes mellitus, (2) congestive heart failure (CHF)—new diagnosis or exacerbation within 30 days of surgery, (3) history of hypertension requiring medication, (4) history of severe chronic obstructive pulmonary disease (COPD), and (5) non-independent functional status (partially or fully dependent). The minimum possible score was 0, while the maximum possible score was 5. The 5-mFI score has been validated in previous studies and has been shown to have a strong predictive ability for postoperative complications, involving a spearmen rho correlation of .95 and C statistic greater than .7.11,13,16,17,24-31
The primary endpoint of this study was 30-day overall complications. Complications were grouped into the following categories: wound complications (superficial infection, deep infection, organ space infection, and wound dehiscence), pulmonary complications (unplanned reintubation, pneumonia, and pulmonary embolus), cardiovascular complications (cardiac arrest, myocardial infarction, and cerebral vascular accident), renal complications (renal insufficiency, acute renal failure, and urinary tract infection) and hematologic complications (bleeding requiring blood transfusion, postoperative sepsis, postoperative septic shock, and deep vein thrombosis). The secondary endpoints for this study included: 30-day readmission, reoperation, length of stay and need to discharge to care facility (acute rehabilitation center or skilled nursing facility).
Statistical Analysis
Patients were grouped based on their 5-mFI score: 5-mFI = 0, 5-mFI = 1, and 5-mFI
Results
Demographics and Preoperative Variables.
SD, standard deviation; BMI, body mass index; 5-mFI, 5-factor modified frailty index.
Univariate Analysis of Preoperative Factors.
SD, standard deviation; BMI, body mass index; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; 5-mFI, 5-factor modified frailty index.
Univariate Analysis of Outcomes Stratified by 5-mFI.
5-mFI, 5-factor modified frailty index; SD, standard deviation.
Multivariate Logistic Regression of Primary and Secondary Outcomes.
5-mFI, 5-factor modified frailty index. CI, confidence interval.
The odds ratio for categorical variables was determined through multivariate logistic regression. All regression models included 5-mFI score, age, sex, body mass index (BMI), dyspnea, preoperative sepsis, concurrent ventral hernia repair, stomal relocation, and bowel resection. Male sex, no dyspnea, no preoperative sepsis, no concurrent ventral hernia repair, no stomal relocation, no bowel resection, and a 5-mFI score of 0 were all used as the referent conditions.
Multivariate Logistic Regression of Additional Risk Factors.
5-mFI, 5-factor modified frailty index. CI, confidence interval.
The odds ratio for categorical variables was determined through multivariate logistic regression, whereas negative binomial regression was used for continuous variables. All regression models included 5-mFI score, age, sex, body mass index (BMI), dyspnea, preoperative sepsis, concurrent ventral hernia repair, stomal relocation, and bowel resection. Male sex, no dyspnea, no preoperative sepsis, no concurrent ventral hernia repair, no stomal relocation, no bowel resection, and a 5-mFI score of 0 were all used as the referent conditions.
Discussion
Frailty is the measure of decreased physiological reserve and the vulnerability to adverse events from physiological and pathologic stressors. 32 A patient’s frailty does not necessarily correlate with an increase in chronologic age. The 5-mFI score, a validated scoring system for frailty, has been established as an important prognosticator of surgical outcomes across various fields of surgery.10,16,33 In general surgery, it has been proven to be an objective metric that physicians can utilize while making preoperative risk stratifications as well as for patient counseling. While previous authors have explored the validity of the 5-mFI score in various types of hernia repairs, there is a dearth of literature regarding its utility as a prognosticator of parastomal hernia repair. To fill the knowledge gap, we performed a retrospective analysis of the ACS-NSQIP database evaluating 2924 patients who underwent elective parastomal hernia repair between 2015 and 2020. We found that when compared to patients with a 5-mFI score of zero, patients with a score of at least 2 were 1.4 times more likely to suffer from 30-day overall complications (primarily attributed to pulmonary, cardiovascular, renal, and hematological complications), 1.5 times more likely to require 30-day unplanned readmission, and 2.5 times more likely to be discharged to a care facility (skill nursing facility and acute rehabilitation center). We also found stomal relocation, and bowel resection as independent risk factors.
Frail patients are at a higher risk of developing postoperative complications. 34 In our study we found that patients with a 5-mFI score of 2 or more, were 1.4 times more likely to have any type of postoperative complications. The significant postoperative complications included pneumonia, unplanned intubations, cardiac arrest, myocardial infarction, postoperative sepsis, and postoperative renal insufficiency. The findings from our study were similar to findings by Balla et al who performed a retrospective analysis of ventral hernia repairs and found that the accumulation of frailty factors was associated with increased frequency of postoperative complications. 16 However, the overall complications rate with 1 and 2 frailty factors in our study was 15.4% and 20.6% compared to 5.1% and 7.6% found in their study. This difference may be attributed to the fact that, while Balla et al 16 investigated a wide range of ventral hernia patient, our study focused solely on parastomal hernia patients—a population that may have undergone more major surgical and medical interventions for underlying disease. Similarly, Chimukangara et al performed a retrospective review and found higher complication rates for patients with increasing frailty scores. 10 They reported a 5.9% and 10.5% overall complication rate for patients with 5-mFI of 1 and 2, respectively. Our study also found that the accumulation of frailty factors was associated with an increase in the rate of postoperative mortality, similar to findings reported by both Balla et al 16 and Chimukangara et al. 10 Finally, we also noted that stomal relocation was a stronger independent risk factor for any overall complications than 5-mFI score of 2 or more.
Our study found that a 5-mFI of 2 or was associated with 1.5 times higher risk of need for readmission. This finding was similar to Wahl et al
27
who in their retrospective review of the NSQIP database showed that an increased number of frailty variables were linearly associated with an increased need for unplanned readmissions after orthopedic, vascular, and general surgeries. Similarly, in a retrospective study of free flap breast reconstruction, Magno-Pardon et al
18
also observe that a 5-mFI
Other studies have suggested that a high frailty score and its associated postoperative complications can lead to a higher likelihood a lengthier hospitalization and being discharged to somewhere other than home.16,39,40 They also determined that frailty was an independent predictor for this disposition, regardless of the complications experienced by patients. Ramdass et al
41
performed a prospective study on hospitalized elderly patients using the Reported Edmonton Frailty Scale (REFS) and found that mildly frail patients were 2.0 times more likely and moderate to severely frail patients were 2.7 times more likely to discharge to a skilled nursing facility or inpatient rehabilitation center. Similarly, Pearl et al performed a retrospective review of radical cystectomy patients and found that patients with a higher level of frailty were 2.3 times more likely to be discharged to inpatient rehabilitation or a skilled nursing facility.
42
In the realm of hernia surgeries, Balla et al
16
and Chimukangara et al
16
both showed that higher frailty was linearly associated with discharge to a location other than home. Along the same lines, our study also found that a 5-mFI
To our knowledge, this is the first study to specifically evaluate the association of 5-mFI with postoperative outcomes and complications after parastomal hernia repair. Preoperative frailty assessment provides an opportunity to improve discussions between clinicians and patients such that they can better anticipate perioperative risk. 43 There are advantages to using this index for risk assessment in surgical populations. It is easy to use and allows for an objective method to calculate surgical outcomes and complications. Furthermore, this index can be used to assess a patient’s physiologic reserve while accounting for age as a confounder. In fact, 5-mFI frailty assessment can identify potentially modifiable components of frailty to rehabilitate patients to enhance their functional capacity to buffer against physiologic stress induced by surgical intervention.44-47
While our study utilized a large patient population, it was not without limitations. Notable limitations associated with the ACS-NSQIP database include inaccurate data entry, complications reported for only 30 days postoperatively, and lack of relevant complications relating to specifically parastomal hernia. Furthermore, this database is limited in providing surgeon-specific information (surgeon experience), facility-specific information (low volume vs high volume center), and surgical techniques used (type of parastomal hernia repair). Although the use of both ICD and CPT codes allowed us to use a systematic approach to identifying patients who underwent parastomal hernia repair, it was limited in recognizing the use of mesh in laparoscopic procedures. While open procedures have an additional CPT code to denote the use of mesh, laparoscopic CPT codes are combined. Due to this limitation, we were unable to reliably analyze the effect of mesh-based repair. Another notable limitation we faced during our analysis was the lack of information regarding bowel preparation—which plays a significant role in wound complications. We were also limited in our analysis because we were unable to identify the reason patients originally received their ostomy. This prevented us from analyzing other confounders such as chemotherapy and radiation treatments. Finally, in our analysis, we found that majority of our patients have hypertension and diabetes as their main comorbidities – therefore, this index may be more reflective of the impact of mainly diabetes and hypertension.
Conclusions
The 5-mFI score is a validated tool to identify ideal candidates for surgical intervention. The purpose of our study was to query the ACS-NSQIP database to assess the utility of the 5-mFI score to risk-stratify patients who need parastomal hernia repair. Our study found that parastomal hernia repair patients with a 5-mFI score of at least 1, had a higher risk of renal, pulmonary, cardiovascular and hematologic complications, readmissions, discharge to care facility, and mortality. Hence, the 5-mFI score can be a useful tool for surgeons during preoperative risk stratification.
Supplemental Material
Supplemental Material - Modified Frailty Index Predicts Postoperative Complications Following Parastomal Hernia Repair
Supplemental Material for Modified Frailty Index Predicts Postoperative Complications Following Parastomal Hernia Repair by Mustafa Khan, Ronit Patnaik, Melinda Lue, Haisar Dao Campi, Lisandro Montorfano, Mauricio Sarmiento Cobos, Roberto J. Valera, Raul J. Rosenthal, and Steven D. Wexner in The American Surgeon™
Footnotes
Declaration of Conflicting Interests
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: None of the authors have relevant financial conflicts of interest to disclose. Dr Wexner reports received consulting fees from ARC/Corvus, Astellas, Baxter, Becton Dickinson, GI Supply, ICON Language Services, Intuitive Surgical, Leading BioSciences, Livsmed, Medtronic, Olympus Surgical, Stryker, Takeda and receiving royalties from Intuitive Surgical and Karl Storz Endoscopy America Inc.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Supplemental Material
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References
Supplementary Material
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