Abstract
Background: Intraperitoneal
drainage during Umbilical Hernia Repair (UHR) in cirrhotic patients is often
used to control postoperative ascites, typically via drain placement or
aspiration. Despite potential complications, many surgeons continue this practice.
This study aimed to compare postoperative outcomes in patients who underwent
UHR with or without drainage.
Methods: The
TriNetX database (Clinical trial database) was used to retrospectively analyze
U.S. patients aged ≥18 years with ascites
who underwent UHR, either with drainage (Cohort 1) or without (Cohort 2).
Drainage was defined as the placement of any intraperitoneal drain or
aspiration. Outcomes included hernia recurrence requiring repair, prolonged
hospitalization, ascites leak, postoperative complications and Surgical Site
Infection (SSI). Propensity score matching was performed using age, MELD lab
values, BMI and comorbidities.
Results: Cohort
1 contained 539 patients and Cohort 2 contained 17,148 patients. 536 patients
per cohort were identified after matching. Patients who underwent drainage had
no statistically significant difference in hernia recurrence rate (OR 1.67, 95%
CI [0.95, 3.29]), length of hospital stay (OR 1.05, 95% CI [0.56, 1.96]),
ascites leak (OR 1.12, 95% CI [0.70, 1.77]) or SSI (OR 1.04, 95% CI [0.70,
2.09]). 42.9% of Cohort 1 versus 36.9% of Cohort 2 had postoperative
complications (OR 1.28, 95% CI [1.004, 1.64]).
Conclusion: Matched
patients with ascites who underwent intraperitoneal drainage procedures
following UHR had no improvement in hernia recurrence, ascites leak, surgical
site infections and length of hospital stay and had a statistically significant
increase in postoperative complications, indicating a lack of benefit to
routine intraperitoneal drainage for UHR.
Keywords: Umbilical hernia, Ascites, Cirrhosis, Drainage, Surgical outcomes, Intraperitoneal drain, Postoperative complications
Abbreviations: UHR: Umbilical Hernia Repair; SSI: Surgical Site Infection; BMI: Body Mass Index; PD: Peritoneal Dialysis; HCOs; Health Care Organizations; MELD: Model for End-Stage Liver Disease; COPD: Chronic Obstructive Pulmonary Disease
1. Introduction
Umbilical
Hernias (UH) are a common complication in cirrhotic patients with ascites. The
hernia can enlarge quickly if not repaired and lead to significant
complications such as bowel strangulation or peritonitis, resulting in severe morbidity1.
Control
of ascites is recommended in the management of umbilical hernias to reduce
recurrence and morbidity rates2.
Medical conservative treatment with diuretics is generally attempted first. If medical management fails, options
for invasive control of ascites include paracentesis, Peritoneal
Dialysis (PD) catheter placement or shunting. These procedures are not without
risks, including infection, bleeding, need for fluid correction causing
electrolyte imbalance, prolonged length of stay and higher hospital costs3-5. Despite these risks, many surgeons
continue to use drains, including closed-suction surgical drains and
subsequently must manage these postoperative complications. Furthermore, the
duration of drainage is unclear and there have not been any large randomized
controlled trials to demonstrate their effectiveness.
The objective of our study was to evaluate patients who
underwent UHR with or without intraperitoneal drainage and to compare the
differences in hernia
recurrence requiring reoperation, length of hospital stay, ascites leak, Surgical
Site Infection (SSI) and postoperative complications.
2. Materials and Methods
2.1.
Data Source
The
data used in this study were collected on October 13th, 2024, from the TriNetX U.S.
Collaborative Network. The TriNetX platform provides access to electronic
medical records from over 110 million patients in 66 Health Care Organizations
(HCOs). The information that is available covers demographics, diagnoses (based
on ICD-10-CM codes for the International Classification of Diseases, Tenth
Revision, Clinical Modification), procedures (coded using ICD-10-PCS or CPT),
medications (coded using the Veterans Affairs National Formulary) and
laboratory tests (coded using Logical Observation Identifiers Names and Numbers
or LOINC). The HCOs include data for patients with or without insurance from
hospitals, primary care clinics or specialists.
2.2.
Patient Consent Statement
TriNetX
complies with the Health Insurance Portability and Accountability Act to
protect the privacy and security of healthcare data. Data is deidentified and
directly retrieved from electronic health record systems of participating
organizations in a systematic and standardized format.
2.3.
Design of Cohort
We used the TriNetX database to conduct a retrospective cohort study of patients aged ≥18 years who had ascites and umbilical hernias. We identified patients who underwent UHR with or without intraperitoneal drainage, whether by any drain of the abdomen or by aspiration. Because intraoperatively placed closed-suction drains lack a procedural code as well as the inherent heterogeneity of real-world practice, we categorized drainage using broader and more comprehensive codes to encompass a wide range of ascites management techniques. While we recognize that these interventions differ mechanistically, they all share the same clinical intent: to control ascites during UHR. By grouping these drainage procedures together, we can examine drainage as a collective management strategy and maximize generalizability. The codes used to build our cohorts were the following:
Repair
of umbilical or ventral hernia: 49560-49566,
49570-49572, 49585-49587, 49652-49657.
Ascites: K70.11,
K70.31, R18-R18.8.
Drainage
of the abdomen: 0K9L, 0K9L00Z, 0K9L30Z, 0K9K, 0K9K00Z,
0K9K30Z, 0H97, 0H97X0Z, 0H97XZX, 0H97XZZ, 0J980ZZ.
Insertion
of tunneled intraperitoneal catheter: 49421-49423.
Abdominal
paracentesis, with or without imaging guidance: 49082,
49083.
Study
participants were divided into two cohorts. Cohort one included patients with
ascites who underwent UHR and received intraperitoneal drainage one day before
or up to one week after surgery. This perioperative window was selected to
reflect the variability in real-world surgical practice and capture the full
spectrum of drainage use based on surgeon preference. Cohort two included
patients with ascites who underwent UHR but did not have any associated
drainage procedure codes.
2.4.
Outcomes
The primary endpoint was postoperative clinical outcomes. These were assessed in patients with ascites who underwent UHR with or without intraperitoneal drainage during the follow-up period, defined as 1 day after the index UHR procedure through 24 months. The outcomes evaluated included:
Hernia
recurrence requiring reoperation: CPT 49565-49566, CPT
49656-49657
Prolonged
hospital course: CPT 99356, 99357, 1013795, 1013800
Continued
ascites leak: ICD-10-CM N39.45, T81.3, T81.30XA,
T81.31, T81.31XA, T81.32, T81.32XA, T85.63, T85.631, T85.631A
Postoperative
complications: ICD-10-CM T80-T88, J95.89
SSI,
superficial and deep: ICD-10-CM T81
2.5.
Statistical Analyses
All statistical analyses were performed using the TriNetX platform. Propensity score matching was utilized to reduce the effect of confounding factors and selection bias. We adopted the TriNetX built-in platform for covariate adjustment, which uses multiple software components to ensure accuracy. We matched the two cohorts at a 1:1 ratio through the greedy nearest-neighbor algorithm. The covariates used were age, lab value components (INR, total bilirubin, creatinine, sodium) for calculating Model for End-Stage Liver Disease (MELD) score, body mass index (BMI) and comorbidities that could affect hernia recurrence, such as diabetes mellitus, tobacco use and chronic obstructive pulmonary disease (COPD). Of note, these covariates were used for matching and adjustment purposes and are not intended to characterize the overall patient population. Balance was assessed by standardized difference, with <0.1 indicating an acceptable match6. For outcomes of interest, we calculated odds ratios (ORs) with 95% Confidence Intervals (CIs). If the 95% CI did not include 1, this indicated statistical significance.
3. Results
3.1.
Study Design
Before propensity matching, cohort one contained 539 patients from 42 HCOs in the U.S. and cohort two contained 17,148 patients from 50 HCOs. After matching, there were 536 patients in each group who had ascites, underwent UHR and were age ≥18 years at the time of hernia repair. The age at index, MELD components, BMI and comorbidities of the two cohorts before and after propensity score matching are presented in (Tables 1-3), respectively.
Table 1: Baseline characteristics of the overall study population.
|
Variables |
Before Matching |
||
|
Intraperitoneal Drainage
Group (n = 539) |
No Drainage Group (n =
17,148) |
Std. diff. |
|
|
Age at Index, Years |
|||
|
Mean ± SD |
56.9 ± 11.4 |
56.7 ± 13 |
0.0202 |
|
MELD component lab
values |
|||
|
INR |
1.29 ± 0.339 |
1.31 ± 2.37 |
0.0102 |
|
Creatinine |
2.39 ± 3.39 |
1.26 ± 2.42 |
0.3864 |
|
Total bilirubin |
1.53 ± 1.9 |
1.02 ± 2.22 |
0.2481 |
|
Sodium |
135 ± 4.68 |
138 ± 3.71 |
0.6029 |
|
Body Mass Index, kg/m2 |
|||
|
Mean ± SD |
27.5 ± 6.06 |
30.5 ± 6.91 |
0.4589 |
|
Comorbidities, n (%) |
|||
|
Diabetes mellitus |
189 (35.2) |
6478 (38.2) |
0.0622 |
|
Tobacco use |
90 (16.8) |
2417 (14.2) |
0.0696 |
|
COPD |
76 (14.2) |
2411 (14.2) |
0.0018 |
Table
2:
Baseline characteristics of the propensity-matched study population. Bold font
represents a standardized difference <0.1.
|
Variables |
After Matching |
||
|
Intraperitoneal Drainage
Group (n = 536) |
No Drainage Group (n =
536) |
Std. diff. |
|
|
Age at index, years |
|||
|
Mean ± SD |
56.9 ± 11.4 |
56.7 ± 12.3 |
0.0203 |
|
MELD component lab values |
|||
|
INR |
1.3 ± 0.339 |
1.26 ± 0.446 |
0.0926 |
|
Creatinine |
2.38 ± 3.38 |
1.8 ± 2.38 |
0.2002 |
|
Total bilirubin |
1.53 ± 1.9 |
1.36 ± 1.81 |
0.0945 |
|
Sodium |
135 ± 4.68 |
137 ± 3.87 |
0.3929 |
|
Body mass index, kg/m2 |
|||
|
Mean ± SD |
27.5 ± 6.06 |
28.4 ± 5.91 |
0.1483 |
|
Comorbidities, n (%) |
|||
|
Diabetes mellitus |
189 (35.3%) |
190 (35.4%) |
0.0039 |
|
Tobacco use |
90 (16.8%) |
70 (13%) |
0.1049 |
|
COPD |
76 (14.2%) |
78 (12.7%) |
0.0438 |
Table 3: Comparison of propensity-matched patients with and without intraperitoneal drainage.
|
Outcomes |
Patient outcome |
|||
|
Intraperitoneal Drainage Group (n = 536) |
No Drainage Group (n = 536) |
OR (95% CI) |
Risk Difference P-value |
|
|
Hernia recurrence requiring reoperation |
23 (4.3%) |
14 (2.6%) |
1.67 (0.85, 3.29) |
0.3132 |
|
Prolonged hospital course |
21 (3.9%) |
20 (3.7%) |
1.05 (0.56, 1.96) |
0.8735 |
|
Ascites leak |
41 (7.7%) |
37 (6.9%) |
1.12 (0.70, 1.77) |
0.6381 |
|
Surgical site infection |
53 (9.9%) |
51 (9.5%) |
1.04 (0.70, 1.56) |
0.8365 |
|
Postoperative complications |
230 (42.9%) |
198 (36.9%) |
1.28 (1.004, 1.64) |
0.046 |
Bold font indicates a statistically significant value. Abbreviations: 95% CI: 95% Confidence Interval; OR: Odds Ratio.
3.2.
Subgroup Analyses
Among patients who underwent intraperitoneal
drainage after UHR, 4.3% experienced hernia recurrence requiring reoperation,
compared to 2.6% of those without drainage (OR 1.67, 95% CI [0.95, 3.29]).
Prolonged hospital stay occurred in 3.9% of the drainage group versus 3.7% of
the non-drainage group (OR 1.05, 95% CI [0.56, 1.96]). Ascites leak was
reported in 7.7% of patients with drainage and 6.9% without (OR 1.12, 95% CI
[0.70, 1.77]). Surgical site infections occurred in 9.9% of the drainage group
versus 9.5% of the non-drainage group (OR 1.04, 95% CI [0.70, 2.09]). The
proportion of patients with other postoperative complications was significantly
higher in the drainage group (42.9%) compared to those without drainage (36.9%)
(OR 1.28, 95% CI [1.004, 1.64]).
4. Discussion
Umbilical
Hernias (UH) are common in cirrhotic patients with ascites. The prevalence has
been reported to be up to 20%, ten times higher than the non-cirrhotic population1. Increased
intra-abdominal pressure from ascites weakens the abdominal wall which, if not
repaired, can result in bowel incarceration or strangulation, rupture of
overlying skin and peritonitis. Ascites control before repair is frequently recommended
to minimize recurrence and postoperative complications such as wound infection
and dehiscence, ascites leak, decompensation of liver disease, hemorrhage and
hernia recurrence2. When medical
treatment fails, many surgeons opt for perioperative ascites drainage at the
time of hernia repair.
Despite
its frequent use, the benefit of drainage during UHR in patients with ascites
remains unclear. In our study of 536 matched patients, perioperative drainage
was not associated with significant improvements in hernia recurrence requiring
reoperation, ascites leak, hospital stay or SSI. However, it was linked to a
statistically significant increase in overall postoperative complications.
Because
closed-suction drains lack a specific procedural code, we included broader
codes for ascites management, including temporary Peritoneal Dialysis (PD)
catheters and paracentesis. These methods were incorporated into our study as
they are commonly coded for peritoneal fluid drainage and can capture the full
spectrum of drainage practices commonly used in clinical settings. PD catheters,
first introduced in 2005, were associated with reduced complications in small
studies, though their optimal duration and risks of bacterial infections and
peritonitis remain concerns7. Paracentesis
avoids indwelling drains but can lead to hernia strangulation due to rapid
fluid shifts8. Large-volume
paracentesis (>5L of ascites), has been linked to acute kidney injury,
hypotension, hepatic encephalopathy and rehospitalization9.
A
survey of 16 surgeons found that 69% would consider a concomitant procedure
during UHR to control ascites, with 9 favoring a PD catheter, one for Peritoneovenous
Shunt (PVS) and one for serial percutaneous drainage10. In addition, three controlled studies in
1984, 1985 and 1990 reported that successful control of ascites reduced hernia
recurrence11-13. However, these
studies were not randomized and two used the now-infrequently used PVS technique.
Furthermore, a U.S. database analysis with the Nationwide Inpatient Sample
showed that among 10,743 patients, drainage procedures increased hospital stay
by 14% and expenses by 29%3.
Fluid shifts after drainage, requiring aggressive fluid and electrolyte
correction, may have contributed to these findings4.
Additionally, drainage carries risks of bleeding, peritonitis and persistent
ascites leak at the insertion site5.
An alternative approach to consider during UHR
is an extraperitoneal repair, as described by Tastaldi
L, et al.14. This
technique begins with de-epithelialization of the hernia sac back to fascia,
followed by closure of the defect with autologous tissue and a secondary
reinforcement with on lay mesh. This method, a modified version of the Chrevel
technique15, avoids abdominal cavity access and prevents potential
enterotomies, wound infections or ascites leak, particularly in high-risk
cirrhotic patients. Additionally, it can be performed under local anesthesia, eliminating
the risks of deep sedation or general anesthesia. A 2010 randomized controlled
trial across four Veterans Affairs medical centers, in which 73 ventral hernias
were repaired laparoscopically and 73 using the open Chevrel method, demonstrated
a lower recurrence rate (8.2%) for the open repair compared to the laparoscopic
approach (12.5%)16.
We acknowledge several
limitations of this study due to its retrospective nature and reliance on accurate
coding data across multiple
institutions. Although we used propensity score matching, residual confounding factors could not be avoided entirely with this
database. For example, we are unable to determine if the UH was repaired in an
emergent or elective fashion, the amount of ascites present, bowel viability, the
size of the hernia defect and the repair technique, all of which may have
contributed to the success or failure of the repair. We are also unable to
determine the severity of patient nutritional state, liver disease or initial
presentation, with the consideration that patients with higher MELD scores or
Child classes and ruptured umbilical hernias may be more likely to undergo
drainage. Furthermore, patients may have been lost to competing healthcare
organizations in the follow-up period and some postoperative complications may
be undercounted. Despite these limitations, the strength of our study is
derived from a large sample size and the analysis of a multicenter cohort study
with a nationally validated set of outcome data and rigorous audit process. We propose
that our outcomes data can be generalized and contribute to the literature regarding
the lack of benefit in routine intraperitoneal drainage for ascites control during
UHR, as well as improve the quality of care in cirrhotic patients.
5. Conclusion
This investigation found no statistically significant difference in hernia recurrence requiring reoperation, ascites leak, SSI and length of stay between patients who underwent perioperative intraperitoneal drainage during UHR and those who did not. However, drainage resulted in a statistically significantly higher rate of overall postoperative complications. Our literature review found that the majority of studies are small and retrospective and there is not enough robust evidence to support routine perioperative intraperitoneal drainage during UHR. The decision for drainage may depend on patient comorbidities, liver disease severity, the urgency of UHR or surgeon preference. A large-scale randomized controlled trial accounting for these factors could better evaluate the outcomes of planned versus unplanned drainage and help identify patients who may benefit from a drain. We also recommend considering an extraperitoneal hernia repair technique to avoid access into the abdominal cavity for high-risk cirrhotic patients.
6. References