Concurrent Inguinal Hernia Repair in Patients Undergoing Minimally Invasive Radical Prostatectomy: A National Surgical Quality Improvement Program Study

Abstract

Objective:

To compare perioperative 30-day outcomes between minimally invasive radical prostatectomy (MIRP) with and without concurrent inguinal hernia repair (IHR) using a national database.

Methods:

The National Surgical Quality Improvement Program database was queried for MIRP from 2012 to 2015. Concurrent IHR was identified using relevant Current Procedural Terminology codes. Primary outcomes were overall complications, reoperations, unplanned readmissions, and mortality within 30 days of MIRP. Secondary outcomes included operative time (OT), length of stay (LOS), prolonged length of stay (PLOS, >2 days), and discharged to continued care (DCC). Multivariable logistic regression was performed to identify the association between concurrent IHR and outcomes.

Results:

A total of 18,065 patients were included; 375 (2.1%) had concurrent IHR. The unadjusted comparison showed no significant difference in overall complication, reoperation, unplanned readmission, or mortality rates between MIRP+IHR and MIRP only groups. OT was longer in the MIRP+IHR group (229 vs 195 minutes, p < 0.001) but no differences were found in LOS, PLOS, or DCC rates. Multivariable logistic regression showed concurrent IHR was not associated with increased odds of overall complication (odds ratio [OR] = 0.83, 95% confidence interval [CI] = 0.49–1.40, p = 0.479), reoperation (OR = 0.57, 95% CI = 0.14–2.30, p = 0.426), unplanned readmission (OR = 0.92, 95% CI = 0.51–1.64, p = 0.771), PLOS (OR = 1.19, 95% CI = 0.86–1.63, p = 0.297), or DCC (OR = 1.94, 95% CI = 0.70–5.34, p = 0.202).

Conclusions:

Concurrent IHR with MIRP was associated with longer OT, but there were no increased 30-day adverse outcomes within the National Surgical Quality Improvement Program (NSQIP) database. These data support the safety of performing concurrent IHR at the time of MIRP and it should be considered to spare men an additional procedure.

Introduction

Prostate cancer is the most common noncutaneous cancer diagnosis in American men and ∼164,690 new cases will be diagnosed in 2018.¹ Minimally invasive radical prostatectomy (MIRP), especially robot-assisted radical prostatectomy (RARP), has become the predominant surgical management for prostate cancer in the United States.^2

–5 Since 2013, it is estimated 140,000 radical prostatectomies (RPs) are performed annually with more than 80% are performed robotically.⁵

More than 99% of prostate cancers are diagnosed in men aged 45 years and older (https://seer.cancer.gov/statfacts/html/prost.html). Studies have shown the lifetime prevalence of inguinal hernia in men >45 years of age range between 28.0% and 46.8%.⁶ Considering the high prevalence of inguinal hernia in men within this age group, it is expected that a considerable number of patients who undergo MIRP may also have coexisted inguinal hernia.^7,8 It is an option for surgeons to concurrently perform inguinal hernia repair (IHR) at the time of MIRP, however, there is concern that concurrent IHR increases the potential of having perioperative adverse events.^9,10

Although there are comparative data between MIRP only and MIRP with concurrent IHR, most studies are single institutional with limited sample size.^11

–14 Thus, meaningful conclusions about the short-term safety of concurrent IHR during MIRP are difficult to make. In this study, we sought to assess whether concurrent IHR performed at the time of MIRP was associated with increased risk of postoperative adverse events by analyzing a validated, large national surgical database.

Methods

Data source

The National Surgical Quality Improvement Program (NSQIP) database from 2012 to 2015 was evaluated for inclusion in the study. NSQIP is maintained by the American College of Surgeons (ACS), and it contains comprehensive data on patient characteristics and 30-day perioperative outcomes. NSQIP database is a validated tool to study the impact of concurrent surgeries on the outcomes of index surgeries.^15,16 Data in the NSQIP database are fully de-identified, thus this study was deemed exempt from review based on our Institutional Review Board guidelines.

Study cohort

Patients who underwent MIRP for prostate cancer were identified through primary Current Procedure Terminology (CPT) code (55866) and ICD-9 diagnosis code (185) or ICD-10 diagnosis code (C61; n = 22,089). We use the term “MIRP” in our study as the CPT code “55866” does not distinguish robotic approach from the conventional laparoscopic approach. However, it is implicit that an overwhelming majority of the cases included in our study were RARPs considering conventional laparoscopic RPs are rarely performed (<1% of all RPs) in the United States since 2010.^5,17 Our study cohort selection process is shown in Supplementary Figure S1 (Supplementary Data are available online at www.liebertpub.com/end). We excluded transferred patients, nonelective cases, and patients with preoperative hospitalizations. We then only included patients with concurrent pelvic lymph node dissection (PLND; CPT codes 38570, 38571, 38572, 38589, and 38770), concurrent IHR (CPT codes 49505, 49520, 49650, and 49652), and no concurrent procedures. Finally, we excluded cases with missing data on any of the co-variables (except race) or outcomes of interest and very small number of cases with operative time (OT) <60 minutes considering the potential coding errors. Our final cohort was categorized into two groups based on whether patients received concurrent IHR (MIRP only vs MIRP+IHR).

Co-variables

We included the following co-variables: age, body mass index (BMI), race, American Society of Anesthesiologists (ASA) score, current smoking status, comorbidity score, and PLND. We calculated the comorbidity score based on the following individual preoperative conditions (one score for each condition) that are consistently collected in the 2012–2015 NSQIP database: diabetes, dyspnea, dependent functional health status, ventilator dependence, chronic obstructive pulmonary disease, ascites, congestive heart failure, hypertension, acute renal failure, on dialysis, open wound, steroid usage, weight loss, bleeding disorder, transfusion, systemic sepsis, and disseminated cancer. The final comorbidity score was categorized into four groups: 0, 1, 2, and ≥3.

Outcomes

Primary outcomes of interest included overall (any) complication, reoperation, unplanned readmission, and mortality within 30 days of MIRP. Eighteen individual 30-day complications were composited into the following: wound (wound dehiscence, superficial, deep, and organ space surgical site infections), pulmonary (pneumonia, reintubation, and ventilator support >48 hours), renal (acute renal failure and progressive renal insufficiency), cardiac (cardiac arrest and myocardial infarction), thromboembolic (deep vein thrombosis and pulmonary embolism), septic (sepsis and septic shock), and other (cerebrovascular accident, urinary tract infection, and transfusion). Overall (any) complication was defined as having any of the 18 complications. Secondary outcomes included OT, length of stay (LOS), prolonged length of stay (PLOS; LOS >2 days), and discharged to continued care (DCC). DCC was defined as discharged to any facilities that were not home, including rehabilitation, separate acute care, and skilled/unskilled care facilities.

Statistical analysis

Patient and perioperative characteristics, and crude adverse event outcomes, were compared between MIRP+IHR vs MIRP only groups using chi-square (χ²) and Wilcoxon rank-sum tests when appropriate. Multivariable logistic regression adjusting for the co-variables was performed to assess the associations of concurrent IHR with the outcomes. All tests were two-sided and p-value <0.05 was considered statistically significant. Analysis was performed using STATA 15 (Stata Corp LP, College Station, TX).

Results

A total of 18,065 patients were included in this study; 17,690 (97.9%) underwent MIRP only and 375 (2.1%) underwent MIRP with concurrent IHR. Baseline patient characteristics are summarized in Table 1. Patients in the MIRP+IHR group were older (64 vs 63 years, p = 0.004). There was a marginal difference in BMI between the MIRP+IHR and MIRP only groups (p = 0.043). No differences were found in race (p = 0.094), ASA score (p = 0.283), smoking status (p = 0.338), comorbidity score (p = 0.768), or PLND (p = 0.283) between the two groups.

Table 1.

Baseline Patient Characteristics Stratified by Concurrent Inguinal Hernia Repair

Patient characteristics	MIRP+IHR (n = 375)	MIRP only (n = 17,690)	p
Age, years, median (IQR)	64 (59–68)	63 (57–67)	0.004
Race, n (%)			0.094
White	295 (78.7)	13,640 (77.1)
Black	30 (8.0)	2005 (11.3)
Other/unknown	50 (13.3)	2045 (11.6)
BMI, kg/m², n (%)			0.043
<25	78 (20.8)	3163 (17.9)
25 to <30	185 (49.3)	7991 (45.2)
30 to <35	79 (21.1)	4641 (26.2)
≥35	33 (8.8)	1895 (10.7)
ASA score, n (%)			0.283
1–2	233 (62.1)	11,465 (64.8)
3–4	142 (37.9)	6225 (35.2)
Smoking, n (%)	40 (10.7)	2177 (12.3)	0.338
Comorbidity score, n (%)			0.768
0	164 (43.7)	7869 (44.5)
1	158 (42.1)	7452 (42.1)
2	45 (12.0)	2109 (11.9)
≥3	8 (2.1)	260 (1.5)
PLND, n (%)	217 (57.9)	9744 (55.1)	0.283

ASA = American Society of Anesthesiologists; BMI = body mass index; IHR = inguinal hernia repair; IQR = interquartile range; MIRP = minimally invasive radical prostatectomy; PLND = pelvic lymph node dissection.

There was no statistically significant difference between MIRP+IHR and MIRP only with 30-day overall complication (4.0% vs 4.8%, p = 0.467), reoperation (0.5% vs 1.0%, p = 0.404), readmission (3.2% vs 3.5%, p = 0.721), or mortality (0.3% vs 0.1%, p = 0.212) (Table 2). Comparison of individual and composite complications are summarized in Supplementary Table S1. There was no significant difference in any of the individual or composite complications between the two groups, including infectious complications. Multivariable logistic regression showed concurrent IHR was not associated with overall complication (odds ratio [OR] = 0.83, 95% confidence interval [CI] = 0.49–1.40, p = 0.479), reoperation (OR = 0.57, 95% CI = 0.14–2.30, p = 0.426), or readmission (OR = 0.92, 95% CI = 0.51–1.64, p = 0.771) (Table 3). Insufficient mortality events precluded a multivariable regression analysis on this outcome.

Table 2.

Unadjusted Comparison of Primary and Secondary Outcomes Between Minimally Invasive Radical Prostatectomy+Inguinal Hernia Repair and Minimally Invasive Radical Prostatectomy Only Groups

Outcomes	MIRP+IHR (n = 375)	MIRP only (n = 17,690)	p
Overall complication, n (%)	15 (4.0)	851 (4.8)	0.467
Reoperation, n (%)	2 (0.5)	169 (1.0)	0.404
Readmission, n (%)	12 (3.2)	627 (3.5)	0.721
Mortality, n (%)	1 (0.3)	14 (0.1)	0.212
Operative time, minutes, median (IQR)	229 (184–277)	195 (157–240)	<0.001
Length of stay, days, median (IQR)	1 (1–2)	1 (1–2)	0.627
Prolonged length of stay, n (%)	45 (12.0)	1818 (10.3)	0.278
Discharged to continued care, n (%)	4 (1.1)	91 (0.5)	0.143

Table 3.

Multivariable Logistic Regression Analysis of Factors Associated with 30-Day Overall Complications, Reoperations, and Unplanned Readmissions

	Overall complication		Reoperation		Readmission
Variables	OR (95% CI)	p	OR (95% CI)	p	OR (95% CI)	p
Concurrent IHR	0.83 (0.49–1.40)	0.479	0.57 (0.14–2.29)	0.426	0.92 (0.51–1.64)	0.771
Age (years)	1.01 (0.99–1.02)	0.317	1.02 (0.99–1.04)	0.144	1.00 (0.99–1.02)	0.554
Race
White	Ref.		Ref.		Ref.
Black	1.44 (1.18–1.76)	<0.001	1.89 (1.28–2.80)	0.001	1.62 (1.30–2.02)	<0.001
Other/unknown	1.22 (0.99–1.51)	0.062	0.84 (0.49–1.45)	0.538	0.96 (0.74–1.26)	0.773
BMI (kg/m²)
<25	Ref.		Ref.		Ref.
25 to <30	1.03 (0.84–1.27)	0.743	1.31 (0.82–2.08)	0.257	1.17 (0.92–1.50)	0.203
30 to <35	1.23 (0.99–1.53)	0.064	1.33 (0.80–2.19)	0.271	1.43 (1.11–1.86)	0.007
≥35	1.18 (0.90–1.55)	0.224	1.37 (0.74–2.52)	0.311	1.45 (1.06–1.98)	0.021
ASA score
1–2	Ref.		Ref.		Ref.
3–4	1.15 (0.99–1.34)	0.063	1.07 (0.77–1.49)	0.692	1.27 (1.06–1.50)	0.008
Smoking	1.04 (0.84–1.27)	0.738	1.43 (0.95–2.16)	0.086	1.04 (0.82–1.32)	0.758
Comorbidity score
0	Ref.		Ref.		Ref.
1	1.15 (0.98–1.35)	0.083	1.29 (0.91–1.82)	0.155	0.99 (0.82–1.18)	0.885
2	1.43 (1.15–1.79)	0.001	1.15 (0.68–1.93)	0.601	1.11 (0.85–1.43)	0.448
≥3	2.23 (1.45–3.42)	<0.001	2.25 (0.93–5.46)	0.072	1.93 (1.19–3.12)	0.008
PLND	1.05 (0.92–1.21)	0.477	0.88 (0.65–2.29)	0.399	1.18 (1.00–1.38)	0.050

CI = confidence interval; OR = odds ratio.

Secondary outcomes demonstrated that the MIRP+IHR group had significantly longer OT than MIRP alone (229 vs 195 minutes, p < 0.001), but no difference was found between the two groups in LOS (1 vs 1 day, p = 0.627), PLOS (12% vs 10.3%, p = 0.278), or DCC (1.1% vs 0.5%, p = 0.143) (Table 2). Multivariable logistic regression showed concurrent IHR was not associated with PLOS (OR = 1.19, 95% CI = 0.86–1.63, p = 0.297) or DCC (OR = 1.94, 95% CI = 0.70–5.34, p = 0.202) (Table 4).

Table 4.

Multivariable Logistic Regression Analysis of Factors Associated with Prolonged Length of Stay and Discharged to Continued Care

	Prolonged length of stay		Discharged to continued care
Variables	OR (95% CI)	p	OR (95% CI)	p
Concurrent IHR	1.19 (0.86–1.63)	0.297	1.94 (0.70–5.34)	0.202
Age (years)	1.02 (1.01–1.03)	<0.001	1.03 (1.00–1.06)	0.057
Race
White	Ref.		Ref.
Black	1.94 (1.70–2.22)	<0.001	1.73 (1.01–2.96)	0.045
Other/unknown	1.55 (1.35–1.79)	<0.001	1.19 (0.64–2.22)	0.581
BMI (kg/m²)
<25	Ref.		Ref.
25 to <30	0.88 (0.77–1.01)	0.070	0.40 (0.24–0.68)	0.001
30 to <35	0.97 (0.84–1.13)	0.712	0.52 (0.30–0.90)	0.020
≥35	1.16 (0.97–1.40)	0.104	0.47 (0.23–0.98)	0.044
ASA score
1–2	Ref.		Ref.
3–4	1.39 (1.25–1.54)	<0.001	1.89 (1.22–2.94)	0.005
Smoking	1.25 (1.09–1.43)	0.002	1.47 (0.87–2.49)	0.153
Comorbidity score
0	Ref.		Ref.
1	1.07 (0.95–1.19)	0.256	1.50 (0.90–2.48)	0.119
2	1.38 (1.18–1.61)	<0.001	2.36 (1.27–4.37)	0.006
≥3	1.54 (1.10–2.15)	0.011	1.94 (0.56–6.74)	0.298
PLND	0.84 (0.76–0.93)	0.001	0.74 (0.49–1.10)	0.138

Discussion

In this analysis of NSQIP data, we demonstrated no significant difference in 30-day adverse outcomes between the MIRP only and MIRP with concurrent IHR. Our findings suggest that concurrently performing IHR at the time of MIRP appears to be safe and does not pose additional morbidity. To our knowledge, this is the largest series to date and the first national study evaluating the impact of concurrent IHR on MIRP outcomes.

Our study is consistent with previous studies in that it further supports the safety of performing concurrent IHR during RARP.^11

–14 Compared with institutional data, the NSQIP database has the advantages of a large sample size and standardized definitions of 30-day adverse events. Lee and coworkers¹³ retrospectively reviewed 1118 consecutive RARPs performed by 1 surgeon and matched 91 cases of RARP alone to 91 cases of RARP with concurrent IHR. Their results showed no differences in LOS or postoperative complications between the two groups. Similarly, Rogers and colleagues¹¹ reported no increase in postoperative 30-day complications after RARP with concurrent IHR. The overall morbidity of RARP is relatively low, especially in the postdissemination robotic surgery era.^18,19 The low morbidity of elective IHR supports why concurrent IHR at RARP does not increase the risk of postoperative adverse events compared with RARP only.^20
–22

Unsurprisingly, our results showed longer OT (34 minutes) in the MIRP+IHR group. Previous institutional series from the United States reported additional OTs needed for IHR were about 10 to 60 minutes.^11,13,14 The variations of the OT difference across studies may not be clinically significant and several factors might account for the variations. For example, Rogers and colleagues¹¹ attributed their longer OT difference to the fact that general surgeons who performed the IHRs were not always immediately available because of being involved in other operations. The 34 minutes of additional OT from a national database should be helpful to counsel the patients if concurrent IHR is planned.

Aside from the evidence showing the safety of concurrent IHR, there are additional potential advantages of performing combined IHR and RARP in one operative setting compared with “staged” operations. First, an additional 10 to 60 minutes in one operation should utilize less healthcare resources than two individual operations. Second, previous IHR may complicate subsequent performance of RARP (especially the PLND) and vice versa. The scarring and adhesions resulting from previous IHR make the PLND more challenging, which may compromise the staging of the prostate cancer for some patients.^23
–25 Similarly, studies have also shown that previous RP can make IHR more difficult than no prior history of RP.^26

–29 Finally, repairing a recognized inguinal hernia during MIRP may decrease the potential risk of post-MIRP bowel incarceration.¹³

In general, there are three inguinal hernia-related scenarios that urologists may encounter before or during a RARP. The patient can have a surgical history of IHR before the RARP, the patient has a diagnosis of inguinal hernia before RARP, or the patient is (incidentally) found to have an inguinal hernia defect during RARP. In addition, inguinal hernia is a well-recognized long-term complication after RP, including MIRP.^28,30 One nationwide, population-based study reported a 3.4-fold increase of IHR after MIRP compared with men without prostate cancer.²⁸ Therefore, it is not uncommon for urologists to see prostate cancer patients with a diagnosed or undiagnosed inguinal hernia. Concurrent IHR at the time of RARP might be a reasonable option for many patients. Urologists should offer men who are undergoing RARP that if a hernia is present either the urologist or general surgeon will repair it at the time of surgery. Communication between urologists and general surgeons coupled with patient counseling are two essential components for optimal decision making. Future studies are also needed to identify which group of patients benefits most from concurrent IHR.

Our study does have limitations inherent to using a large administrative database. First, there was no information related to the inguinal hernia diagnosis since MIRP for prostate cancer was the index surgery in this cohort. While the CPT codes we used to identify IHR excluded incarcerated or strangulated hernia, we do not know other characteristics of the “hernia” (e.g., direct vs indirect, unilateral vs bilateral, preoperative diagnosis vs incidental finding, symptomatic vs asymptomatic), which may have impact on outcomes such as OT. Second, the approaches and techniques used for IHR (e.g., mesh vs no mesh) are also not available in the NSQIP database, which may have impact on infectious complications. In addition, we cannot know with certainty whether the IHR was performed by the urologist or the general surgeon. Third, although NSQIP provides comprehensive data on 30-day complications; most of them tend to be strictly defined and are restricted to the ones that are routinely captured. Finally, our study only focused on 30-day morbidity; long-term efficacy and patient satisfaction of the IHRs are less clear. Future studies with long-term follow-up comparing the outcomes after concurrent IHR vs “staged” IHR (before RARP or after RARP) are needed.

Conclusions

Concurrent IHR with MIRP was associated with longer OT, but there were no increased 30-day adverse outcomes within the NSQIP database. These data support the safety of performing concurrent IHR at the time of MIRP and it should be considered to spare men an additional procedure.

Disclaimer

The ACS-NSQIP and the hospitals participating in the ACS-NSQIP are the sources of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

Abbreviations Used

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