Laparoscopic total extraperitoneal inguinal hernia repair is safe and feasible in patients with continuation of antithrombotics.

AIMS: We aimed to evaluate the safety and feasibility of laparoscopic total extraperitoneal (TEP) inguinal hernia repair in patients with the continuation of their antithrombotic agents. SETTINGS AND
DESIGN: This was prospective cohort study.
MATERIALS AND METHODS: A total of 115 patients who underwent TEP inguinal hernia repair between January 2015 and September 2016 were included in the analysis. Seventeen patients continued their antithrombotics (antithrombotic group); the other 98 had not been on antithrombotics (control group). STATISTICAL ANALYSIS USED: The analysis was performed by using Mann-Whitney U-test, Chi-square or Fisher's exact test.
RESULTS: The antithrombotic group had a greater mean age (65.9 ± 8.0 vs. 57.7 ± 13.6,P= 0.002) and higher prevalence of hypertension (64.7% vs. 33.7%,P= 0.015), cardiovascular diseases (64.7% vs. 7.1%,P < 0.001), atrial fibrillation (23.5% vs. 0,P < 0.001), ischaemic heart disease (35.3% vs. 0,P < 0.001) and the American Society of Anaesthesiologists ≥2 (94.1% vs. 81.6%,P= 0.005). The operation time for the antithrombotic group was longer than that of the control group (92.06 ± 32.81 min vs. 72.33 ± 20.99 min,P= 0.015). None experienced conversion to open surgery in either group. There was no difference in the post-operative complications (29.4% vs. 28.6%) and sero-haematoma formation (23.5% vs. 11.1%). The analgesic requirement, hospital stays (23.72 ± 7.74 vs. 22.35 ± 10.33 h) and the time for return to normal daily activity (3.56 ± 1.74 vs. 3.63 ± 1.90) were not statistically different between the two groups. None in either group experienced major cardiovascular events within 30 days.
CONCLUSIONS: Laparoscopic TEP inguinal hernia repair can be safely performed in patients with the continuation of their antithrombotic agents in experienced hands.

INTRODUCTION

Inguinal hernia is a common condition, and the incidence and the need for surgical repair significantly increase with age. While the elderly population has a high prevalence of cardiovascular diseases or unfavourable cardiovascular risk, it is not uncommon that an aged surgical candidate is taking antiplatelets or anticoagulants. Clinically, whether to withdraw or to continue the antithrombotic agents in the perioperative period of an elective surgery such as an inguinal hernia is often a dilemma. The decision must weigh individual's risk for thromboembolic events and the risk of bleeding related to the procedure.

While the discontinuation of antithrombotic medications decreases bleeding during the operation and postoperatively, it nevertheless carries a substantial risk of thromboembolic events, especially in high-risk patients.[1] In a systematic review of 1868 patients on long-term oral anticoagulants undergoing a variety of invasive procedures, 29 (1.6%) thromboembolic events occurred, while the thromboembolic rate in those who remained on anticoagulant during their procedure was only 0.4%.[2] It was shown that in patients taking low-dose aspirin for the secondary prevention of cardiovascular or cerebrovascular events, discontinuation increases the risk of ischaemic stroke or transient ischaemic accident by 40% compared with continuation of therapy.[3] In addition, strokes occurring after antithrombotic withdrawal have a higher morbidity and mortality than strokes in patients who continue the medications.[45] Acute coronary syndrome or stroke appears to cluster in the first one to 2 weeks after medication withdrawal.[6]

Laparoscopic total extraperitoneal (TEP) repair has become an established minimally invasive approach for inguinal hernia. The literature review showed that the rate of bleeding in TEP was as low as 0.41%.[7] Although the generally low bleeding risk, there is still concern about whether the extensive dissection of the pre-peritoneal space in patients with antithrombotics or coagulopathy leads to significant haemorrhage.[8] Recent studies revealed that in patients undergoing antithrombotic therapy TEP hernia repair can be safely performed during discontinuation of the antithrombotics with or without heparin bridging therapy.[910] However, in those high-risk patients who should not risk antithrombotic withdrawal, the safety and feasibility of continuing the antithrombotic medication perioperatively remain to be determined. The paucity of evidence-based data prompted us to conduct the current study.

MATERIALS AND METHODS

The prospective cohort study included 115 patients who underwent TEP inguinal hernia repair between January 2015 and September 2016. Preoperatively, a total of 17 patients (the antithrombotic group) had been treated with antiplatelets or anticoagulants, including aspirin in nine patients, clopidogrel in three, warfarin in two, and ticlopidine, dabigatran and dipyridamole in one, respectively. The other 98 patients were not taking any antithrombotic medications and were considered as the control group. In all patients, a conventional TEP hernia repair was performed as it has been described.[11] All procedures were performed by a single surgeon. The study protocol was approved by a Local Institutional Review Board (01-X18-063).

Demographic data including age, gender, Body Mass Index, comorbidities, medications, pre-operative symptoms, the American Society of Anesthesiologists (ASA) score and hernia characteristics were prospectively collected. The intraoperative findings (the type and size of the inguinal hernia), operative time, conversion to open surgery and the intraoperative complications (peritoneal tear, inferior epigastric vessel injury and other visceral injury) were recorded. Post-operatively, we assessed and recorded the modified medical outcome score, analgesic requirements, post-operative complications, sero-haematoma formation, hospital stay, days of return to normal activity, hernia recurrence, major cardiovascular events within 30 days and follow-up period.

Statistical method

Continuous data were summarised as a mean ± standard deviation and categorical data were summarised as n (%). Data are compared using two-sample t-test for continuous data with normal distribution, Mann–Whitney U-test for continuous data without normal distribution, Pearson Chi-square or Fisher's exact test for categorical data. All statistical assessments are two-tailed and considered significant as P < 0.05. Statistical analyses were performed with IBM SPSS statistical software version 22 for Windows (IBM Corp., New York, USA).

RESULTS

The demographic data of the 17 patients (the antithrombotic group) and 98 (the control group) are shown in Table 1. Both groups had a similar gender distribution, body habitus, whereas the antithrombotic group had a greater mean age (65.9 ± 8.0 vs. 57.7 ± 13.6, P = 0.002) and higher prevalence of hypertension (64.7% vs. 33.7%, P = 0.015), cardiovascular diseases (64.7% vs. 7.1%, P < 0.001), atrial fibrillation (23.5% vs. 0, P < 0.001), ischaemic heart disease (35.3% vs. 0, P < 0.001) and ASA ≥2 (94.1% vs. 81.6%, P = 0.005).

Table 1

Demographics of the 115 patients who underwent total extraperitoneal inguinal hernia repair

Variables	Total (n=115)	Antithrombotic (n=17)	Control (n=98)	P
Male gender	108 (93.9)	16 (94.1)	92 (93.9)	NS
Age (years)	59.0±13.2	65.9±8.0	57.7±13.6	0.002
Height (m)	1.67±0.08	1.68±0.06	1.67±0.08	NS
Weight (kg)	66.00±11.92	68.49±9.85	65.57±12.24	NS
BMI (kg/m2)	23.60±3.48	24.26±2.66	23.49±3.60	NS
Smoking
Yes	9 (7.8)	0	9 (9.2)	NS
Never	96 (83.5)	15 (88.2)	81 (82.7)
Quit	10 (8.7)	2 (11.8)	8 (8.2)
Hypertension	44 (33.9)	11 (64.7)	33 (33.7)	0.015
DM	18 (15.7)	3 (17.6)	15 (15.3)	NS
Hyperlipidemia	5 (4.3)	1 (5.9)	4 (4.1)	NS
Cardiovascular disease*	18 (15.7)	11 (64.7)	7 (7.1)	<0.001
Atrial fibrillation	4 (3.5)	4 (23.5)	0	<0.001
Ischemic heart disease	6 (5.2)	6 (35.3)	0	<0.001
Cerebrovascular disease	3 (2.6)	2 (11.8)	1 (1.0)	0.01
ASA
1	19 (16.5)	1 (5.9)	18 (18.4)	0.005
2	90 (78.3)	12 (70.6)	78 (79.6)
3	6 (5.2)	4 (23.5)	2 (2.0)
Clinical symptoms
None	1 (0.8)	0	1 (1.0)	NS
Pain	2 (1.8)	1 (6.3)	1 (1.0)
Bulging	62 (55.4)	8 (50.0)	54 (56.3)
Both pain and bulging	47 (42)	7 (43.8)	40 (41.7)
Primary or recurrent
Primary	96 (85.0)	13 (76.5)	83 (86.5)	NS
Recurrent	17 (15.0)	4 (23.5)	13 (13.5)

*Cardiovascular diseases include coronary heart disease, cerebrovascular disease, valvular heart disease, cardiac arrthymia, and congestive heart failure. NS: Not significant, BMI: Body mass index, DM: Diabetes mellitus, ASA: American Society of Anesthesiologists

The operation time for the antithrombotic group was longer than that of the control group (92.06 ± 32.81 min vs. 72.33 ± 20.99 min, P = 0.015). None experienced conversion to open surgery in either group. The amount of blood loss was similar between the two groups, and none experienced blood transfusion. There was no significant difference regarding laterality, type and size of a hernia. The incidence of the peritoneal tear, inferior epigastric vessel injury and other visceral injury was not different between the two groups [Table 2].

Table 2

Intraoperative parameters

Variables	Total (n=115)	Antithrombotic (n=17)	Control (n=98)	P
Operation time (min)	75.10±23.84	92.06±32.81	72.33±20.99	0.015
Conversion to open surgery	0	0	0	NA
Blood loss (ml)
0-10	113 (98.3)	16 (94.1)	97 (99.0)	NS
11-100	2 (1.7)	1 (5.9)	1 (1.0)
Blood transfusion	0	0	0	NA
Hernia laterality
Left	53 (46.1)	13 (76.5)	40 (40.8)	NS
Right	54 (47.0)	3 (17.6)	51 (52.0)
Bilateral	8 (7.0)	1 (5.9)	7 (7.1)
Type
Indirect	71 (64.0)	11 (64.7)	60 (63.8)	NS
Direct	38 (34.2)	6 (35.3)	32 (34.0)
Femoral	2 (1.8)	0	2 (2.1)
Size (EHS classification) (cm)
<1.5	9 (8.1)	1 (5.9)	8 (8.5)	NS
1.5-3.0	64 (57.7)	10 (58.8)	54 (57.5)
>3.0	38 (34.2)	6 (35.3)	32 (34.0)
Peritoneal tear
No	64 (55.7)	52 (53.1)	12 (70.6)	NS
Tear, repair not required	26 (22.6)	22 (22.4)	4 (23.5)
Tear, repair required	25 (21.7)	24 (24.5)	1 (5.9)
Inferior epigastric vessel injury
No injury	112 (97.4)	16 (94.1)	96 (98.0)	NS
Injury, ligation not required	2 (1.7)	0	2 (2.0)
Injury, ligation required	1 (0.9)	1 (5.9)	0
Other visceral injury#	0	0	0

#Includes injury to bowel, major vessels, spermatic vessel, and vas deference. NA: Not assessed, NS: Not significant, EHS: European hernia society

Table 3 shows the post-operative outcomes. The medical outcome scores on post-operative day 1 and day 7 and the analgesic requirement were not statistically different between the two groups. There was no difference in the post-operative complications (29.4% vs. 28.6%) and sero-haematoma formation (23.5% vs. 11.1%). There was no significant difference in hospital stays after the operations (23.72 ± 7.74 vs. 22.35 ± 10.33 h) and the time for return to normal daily activity (3.56 ± 1.74 vs. 3.63 ± 1.90). None experienced major cardiovascular events within 30 days.

Table 3

Post-operative outcomes

Variables	Total (n=115)	Antithrombotic (n=17)	Control (n=98)	P
Modified medical outcome score
Post-operative day 1	22.22±3.32	22.41±2.92	22.18±3.40	NS
Post-operative day 7	26.75±1.47	27.12±1.17	26.68±1.52	NS
Analgesics requirement (mg/kg)
Total acetaminophen dose	57.20±70.08	64.06±66.62	56.09±70.90	NS
Equivalent morphine doses	0.01±0.03	0.01±0.033	0.01±0.035	NS
Post-operative outcomes (%)
Post-operative complications#	33 (28.7)	5 (29.4)	28 (28.6)	NS
Post-operative sero-hematoma	15 (13.2)	4 (23.5)	11 (11.3)	NS
Hernia recurrence	1 (0.9)	0	1 (1.0)	NA
Hospital stay after operation (h)	22.54±9.99	23.72±7.74	22.35±10.33	NS
Return to normal daily activity (days)	3.62±1.87	3.56±1.74	3.63±1.90	NS
Major cardiovascular event in 30 days	0	0	0	NA
Mean follow-up (months)	6.06±0.93	6.00±0.00	6.07±1.00	NS

#Post-operative complications include wound infection, epididymitis, urinary tract infection, urinary retention, and sero-hematoma. NA: Not assessed, NS: Not significant

DISCUSSION

In the present study, TEP inguinal hernia repair was successfully completed in all patients with the continuation of their antithrombotics without any conversion, and there was no major bleeding or other severe complications during the intra-operative and post-operative period. The incidences of post-operative complications and sero-haematoma formation in the patients on antithrombotics were similar to the controls. These findings suggest that TEP hernia repair is a safe and feasible procedure in patients whose antithrombotics should not be withdraw before the procedure.

The perioperative management of antithrombotic therapy in TEP inguinal hernia repair has been rarely addressed in the literature. Wakasugi et al.[9] in their study reported a series of TEP inguinal hernia repair in 22 patients on antithrombotic agents and 55 controls. The antithrombotic agents were discontinued in all the 22 patients; nine of them did not receive any adjunctive therapy and the other 13 received heparin bridging therapy. The clinical outcomes were similar between the antithrombotic and the control groups regarding the operative time, bleeding volume, hospital stay and the occurrence of sero-haematoma, haematoma and thrombotic events.[9] More recently, the same investigating group further reported a series of single-port TEP hernia repairs, which comprised 92 patients on antithrombotic agents and 273 controls. The perioperative manipulation of the antithrombotic medications included discontinuation without heparin bridging in 53, discontinuation with heparin bridging in 36 and continuation in only three. The clinical outcomes among the three manipulations were similar about the operative time, bleeding volume, as well as the rate of sero-haematoma formation or wound infection. The post-operative hospital stay in patients with continued antithrombotics was significantly shorter than those with discontinuation. These findings generally suggest that TEP an inguinal hernia is safe when discontinuing the antithrombotic agents, with or without heparin bridging therapy.

However, to withdraw the antithrombotic therapy significantly increases the risk of thromboembolic events, especially in those with high cardiovascular risk.[23] The current guidelines also recommend the perioperative management of the antithrombotic therapy should be determined by balancing the bleeding risk of the procedure and the thromboembolic risk of the patient.[1213] The continuation of antithrombotic therapy in TEP inguinal hernia repair has been rarely addressed in the literature. Moreover, to the best of our knowledge, the current study is by far the largest series. To achieve a successful procedure in patients on antithrombotics, several points in our technique should be recognised. First, the use of balloon dilators in creating the pre-peritoneal space at the beginning of this procedure should be done extremely carefully. We suggest that the blind balloon dilatation should be limited in the middle part, simply enough for the other two trocars to be inserted. Then, the pre-peritoneal dissection is continued laterally under vision to avoid significant bleeding. Second, all the surgical steps should be taken subtly. A perfect haemostasis should be achieved by cauterisation of all the bleeding areas. The more delicate dissection and haemostasis explain the longer operation time in the antithrombotic group. Third, at the end of the procedure, we suggest that one should turn down the abdominal pressure to 5 mmHg, to make sure there is no venous bleeding masked by a high abdominal pressure.

Without high-level evidence, the optimal approach to inguinal hernia repair remains to be determined. Previous studies have revealed that anticoagulants increase the risk of post-operative bleeding in open hernioplasty.[141516] On the other hand, Sanders et al.[15] revealed that open inguinal hernia mesh repair can be safely performed in patients on warfarin with an INR of 3 or less. A recent study based on data from the Herniamed Hernia Registry revealed that coexisting coagulopathy and antithrombotic therapy are associated with a four-fold risk of post-operative bleeding after open or laparoscopic inguinal hernia repair.[8] However, despite endoscopic inguinal hernia repair requiring an extensive dissection, the risk of bleeding complications and complication related reoperation appears to be lower.[8] The study generally confirmed the view that the subtle dissection technique applied in the endoscopic repair procedure appears to present a low risk of bleeding, which makes it a safe and feasible procedure.

There are several limitations to the current study. First, the number of patients continuing antithrombotic agents was small, although this is by far the largest series we have seen in the literature. Further investigation with more patients enrolled is still required. Second, all the procedures in the series were performed by an experienced laparoscopic surgeon. Whether the results apply to a surgeon with less experience requires further investigation. Third, our results do not necessarily mean that all procedures should be performed with the continuation of antithrombotic agents. The decision should be still made by carefully balancing the benefit-risk ratio.

CONCLUSIONS

The present study revealed that in experienced hands laparoscopic TEP hernia repair is a feasible and safe procedure in patients with the continuation of their antithrombotic medications.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.