Recurrence after inguinal hernia repair at ten years by open darn, open mesh and tep — No advantage with mesh

Recurrence after inguinal hernia repair at ten years by open darn, open mesh and tep — No advantage with mesh

original article RECURRENCE AFTER INGUINAL HERNIA REPAIR AT TEN YEARS BY OPEN DARN, OPEN MESH AND TEP – NO ADVANTAGE WITH MESH S. J. Nixon H. Jawaid...

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RECURRENCE AFTER INGUINAL HERNIA REPAIR AT TEN YEARS BY OPEN DARN, OPEN MESH AND TEP – NO ADVANTAGE WITH MESH

S. J. Nixon H. Jawaid Royal Inrmary Edinburgh Correspondence to: Mr Steve Nixon, Ward 106 Royal Inrmary Hospital Little France, Edinburgh EH16 4SA Tel: +44(0)778 571 2468 Email: [email protected]

Background: Whilst mesh repair is now standard in inguinal hernia surgery, with the expectation of a reduction in recurrence rate, the incidence of recurrent hernias shows little evidence of decline. Longterm follow-up studies after hernia surgery are few. Methods: 1361 patients underwent 1473 inguinal hernia repairs by open mesh, open sutured or total extraperitoneal (TEP) techniques with more than ten years’ follow-up. Findings: Recurrence rates after open mesh and open sutured repair were similar. There has been no benet in terms of declining recurrence from the increasing use of mesh. There was a high rate of early recurrence after TEP due to learning curve effects. Late recurrence, occurring after two years’ was uncommon with all techniques, but was lowest after TEP, double the rate after open mesh and four times the rate after sutured repair. This may be due to mesh protecting the area of muscle weakness’ with larger meshes conferring a greater long-term benet. Conclusion: Our ndings help to explain why there has been no signicant fall in the incidence of recurrent inguinal hernias in national data sets and large scale audits, despite a widespread use of mesh. keywords: recurrence, inguinal hernia, mesh, sutured, laparoscopic, extraperitoneal, TEP Surgeon, 1 April 2009, pp. 71-4

Introduction Open mesh repair for inguinal hernia is considered the gold standard technique based on trials demonstrating lower recurrence rates.1 These early trials, and more recent studies of laparoscopic surgery, are, however, based on short-term follow-up, typically two years. Little is known of longer term results but one RCT has shown significant advantage of mesh over suture repair at ten years, reporting recurrence rates of 1% and 17% respectively.2 National audit data, however, have not shown a dramatic decrease in the number of repairs for recurrent hernia and the impact of mesh repair has not been as great as one might have hoped.1 A recent publication, using the Danish Hernia Registry, has examined follow-up beyond five years and shows that mesh repair consistently out-performs suture repair in terms of recurrence.3 It also shows that in the longer term, late failures after mesh repair are uncommon in contrast to sutured repair where recurrences continue to occur at a steady rate. © 2009 Surgeon 7; 2: 71-4

We have developed the Danish approach further by studying patients treated in Lothian, Scotland, where a computerised data base of operations has existed since 1983 and has gathered very detailed data since 1992. During the period 1983 to 2007, the number of patients undergoing inguinal hernia surgery has remained constant and the proportion of patients having surgery for recurrent hernia has not fallen despite almost 100% conversion to mesh repair around 1996 (Figure 1). We have examined the long-term recurrence rates in patients having inguinal hernia surgery at least ten years ago by open sutured, open mesh and laparoscopic TEP mesh surgery.

Methods The Lothian Surgical Audit has prospectively collected surgical activity data on computer since 1983 including all operation notes, clinical letters and discharge summaries. In 1993, a the royal colleges of surgeons of edinburgh and ireland | 71

table 1. Details of the three operations Open mesh

Open suture

Patients

573

499

289

Bilateral repairs

40 (7%)

37 (7%)

35 (12%)

Total hernia repairs

613

536

324

Female

24 (4%)

40 (8%)

16 (9%)

Median age

64

62

59

Recurrent hernia repair

71 (12%)

44 (9%)

27 (9%)

Recurrences found

25 (4%)

22 (4%)

TEP

23 (7%)

more sophisticated coding system allowed distinction between sutured versus mesh repair, and open versus laparoscopic repair. During the period of study, sutured repair was usually a monofilament nylon or polypropylene darn between inguinal ligament and conjoint tendon. Mesh repair followed Lichtenstein principles and used a polypropylene mesh fixed by a continuous polypropylene suture to the inguinal ligament and interrupted sutures to the medial and upper margins of the mesh. TEP was undertaken using a 10x15cm polypropylene mesh in most cases. A list of patients undergoing unilateral, bilateral, primary and recurrent inguinal hernia surgery between January 1993 and December 1997 in the Western General Hospital, Edinburgh was obtained. Patient age and sex were recorded. The consultant responsible for clinical care was also identified. During this period, the decision to undertake open suture, open mesh or laparoscopic repair was at the discretion of the consultant. All subsequent surgical documents relating to these patients up to September 2007 from both the Western General Hospital and the Edinburgh Royal Infirmary were extracted from the data set. These documents were then subjected to a ‘word search’ using a query in Microsoft Access to find occurrences of the word ‘hernia’ or ‘recur’ in any subsequent operation notes, clinic letters or discharge summaries. Any relevant document was examined and patients with a hernia recurrence were identified. All later operation codes and discharge summaries were also studied. The date of recurrence was recorded as the first date that evidence of recurrence was recorded, either on clinical examination or at subsequent surgery. No attempt was made in this study to identify patients who had died in the follow-up period. No attempt was made to contact individual patients. The follow-up was entirely based on the re-presentation of the patient to an Edinburgh surgical unit, all of which use the Lothian Surgical Audit system, with the exception of the local private hospital whose records were not examined. Statistical comparison of 2x2 data was by Fisher’s Exact Test, and Kaplan-Meier plots and log rank analysis were obtained using EpiInfo.

Results One thousand three hundred and sixty-one patients underwent initial inguinal hernia surgery during the study period, 112 of whom had 72

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table 2. Percentage recurrence rates by consultant team and technique Consultant

Open mesh

Open suture

TEP

A

6.4

5.1

0*

B

2.4

2.6

7.5

C

3.2

4.4

5.4

D

0*

3.4

12*

* indicates small numbers of cases

a bilateral repair; there were 1473 repairs in total. Two hundred and eighty-nine patients had TEP, 573 had open mesh and 499 had sutured repair. One hundred and forty-two patients had surgery for recurrent hernia. There were 1321 males and 40 females. The median age was 59 for TEP, 64 for mesh and 62 for sutured repair. The distribution by age, bilaterality, primary vs recurrent and sex is shown in Table 1 for the three types of repair Sixty-eight patients were identified as having a recurrence, in two both sides recurring at the same time, making a total of 70 recurrent hernias. The overall recurrence rate was 4% after both open mesh and open sutured repair and 7% after TEP (Table 1). There were two recurrences in female patients (5%) and 66 (4.6%) in male patients (NS). Recurrence rate after bilateral repair was 5.4% and after re-repair for recurrence was 9.9%. The open mesh group had the highest proportion of repairs for recurrence (12% vs 9% vs 9%) and was slightly older (median age 64 vs 62 vs 59). An actuarial graph of recurrence is shown in Figure 2. Surprisingly, for open surgery, the best results were obtained after sutured repair, although the two curves converge at ten years. There was no statistically significant difference between open mesh and open suture recurrence (p>0.9). TEP shows a high early failure rate, as expected, during the early learning curve of surgeons. Both open techniques had significantly lower recurrence rates then TEP (mesh vs TEP p<0.04, suture vs TEP p<0.04). Taking a cut-off of at 26 months to distinguish ‘early’ and ‘late’ recurrence, our data show that the risk of late recurrence between two and eight years is 2.6 per 100 patients per eight years for sutured repair, 1.6 per 100 for mesh repair and 0.6 per 100 for TEP repair. Whilst early failure was more common after TEP than open surgery, late failure was less common. To exclude the possibility that a single surgeon with either excellent or poor results may have affected the results of this study, an analysis by surgical team was performed. A total of nine consultants had responsibility for the patients but four consultants had contributed 96% of the cases. Table 2 shows the recurrence rates by consultant and the operative technique of these four surgeons. There were no significant differences in recurrence rates for any surgeon between techniques and no significant differences in recurrence rates between surgeons for any single technique. The five low volume consultants performed only 4% of the operations but had 16% of the recurrences, in keeping with the observation that high volume generally correlates with better results.

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Fig. 1. Percentage of inguinal hernia operations performed for recurrent hernia between 1984 and 2007 in Lothian, Scotland

Fig. 2. Actuarial plot of recurrence after TEP, open mesh and open sutured inguinal hernia repair by months of followup (EpiInfo) © 2009 Surgeon 7; 2: 71-4

the royal colleges of surgeons of edinburgh and ireland | 73

Discussion Long-term follow-up presents major difficulties in all surgical research and little data exist for late failure after hernia surgery. Flum reported long-term results after sutured and mesh repair for incisional hernia, from which he concluded that the expected major improvement in outcome as measured by recurrence had not been found.4 Although mesh repair was slightly superior to sutured repair, he showed that mesh delays rather than prevents recurrence, the delay being less than two years, and the graphs of recurrence after mesh and sutured repair were parallel rather than diverging. Similar epidemiological data were used for inguinal hernias from the Danish Hernia Registry where re-operation was used to identify recurrence. They also found that mesh repair had consistently lower recurrence rates than sutured repair, but also that the graphs widely diverged over time. Sutured repairs continue to fail at a constant rate over time, whereas mesh repairs appear to have a low rate of late failure. We have used re-presentation to an Edinburgh surgical unit to identify recurrence. Both Scottish and Danish studies under-estimate the true recurrence rate.2 Some patients will have moved out of our area or have died. Others will have had surgery elsewhere, such as in private clinics, and some will have chosen not to seek further surgical advice. Our data may be influenced by our contribution to the MRC trial of laparoscopic surgery as patients entered into this trial were followed-up annually for three years.5 This may have increased the pick-up rate for recurrence after both the open mesh and the TEP cases. However, only 200 patients from our hospital were included in this study out of 857 who underwent a mesh repair and we believe that any effect on our data would be small. We also found that most recurrences were detected by general practitioners and referred back to our clinics and very few were detected at post-trial follow-up. Mesh repair was introduced to Lothian in the early 1990s and our study included patients in the early learning curve for this operation. It is generally believed that the Lichtenstein operation is relatively easy to learn and tolerant of less than ideal surgery. Interestingly, our two year recurrence rate after open mesh repair is slightly less than 2%, which compares favourably with the 2.1% reported by NICE in randomised trials of open vs laparoscopic surgery.6 Also, our recurrence rate and pattern are essentially identical to those reported from the Danish group. It appears, therefore, that our surgeons were performing open mesh repair to an acceptable standard during this study period, as were surgeons in Denmark. There is a contrast between our findings and those from Denmark after open sutured repair. The explanation for this difference may be in the high use of ‘annulorrhaphy’ in Denmark. Of 4932 sutured repairs in the Danish study, 2555 (52%) used this technique which is not described in detail in their paper. We presume that the operation entails the closure of the deep inguinal ring with no formal posterior wall repair. The Danish study has not analysed individual surgeon results. Nonetheless, for open mesh repair, Danish and Scottish surgeons appear to have identical results, whereas after sutured repair, Scottish surgeons appear to have better results. The reasons for this difference are not clear. The actuarial graph demonstrates the high rate of early recurrence after TEP which we believe is due to the steep learning curve. We have previously reported an in depth analysis of TEP recurrences and

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the reasons we believe these failures occur.7 We showed that our high rate of early recurrence fell dramatically as our experience grew. The mechanism for late recurrence after surgery may be different after sutured and mesh repair. For sutured repair, we presume that the patient’s tissues simply become increasingly weak over time, stretching and allowing the muscle defect to reform. After mesh repair, we presume that the mesh either contracts or slowly migrates until the muscle weakness is re-exposed and the hernia recurs. Typically, a laparoscopic surgeon places a 150cm2 mesh, in contrast to the open mesh operation where the area of mesh will be less than half that and may even be as little as 50cm2 in area. It would seem logical to presume that re-exposure of the muscle defect is likely to occur at an earlier stage if a smaller mesh is used. Our finding that late recurrence after TEP, even when performed by surgeons in the early learning curve, is less common than after open mesh repair would support this hypothesis. In our patients, the rate of late recurrence between two and ten years after surgery is two and half times greater after open mesh than after TEP repair and four times greater after open suture repair compared with TEP. In conclusion, patients operated on more than ten years ago for inguinal hernia have not gained any benefit in terms of recurrence from the increased use of mesh over suture techniques. Our results help to explain why the number of patients presenting with recurrent inguinal hernia in Lothian has not fallen. TEP is associated with the lowest rate of late recurrence, possibly due to the use of a larger mesh, and offers hope of a reduction in hernia recurrence in the longer term.

Copyright © 13 January 2009 REFERENCES 1. Schumpelick V, Klinge U. Prosthetic implants for hernia repair. Br J Surg 2003; 9 : 1457-58 2. van Veen RN, Wijsmuller AR, Vrijland WW et al. Long-term follow-up of a randomized clinical trial of non-mesh versus mesh repair of primary inguinal hernia. Br J Surg 2007; 94: 506-10 3. Bisaard T, Bay-Nielsen M, Christensen IJ et al. Risk of recurrence 5 years of more after primary Lichtenstein mesh and sutured inguinal hernia repair. Br J Surg 2007; 94: 1034-40 4. Flum DR, Horvath K, Koepsell T. Have Outcomes of incisional hernia repair improved with time ?: A population based analysis. Ann Surg 2003; 237(1) : 129-135 5. Laparoscopic versus open repair of groin hernia: a randomised comparison. The MRC Laparoscopic Groin Hernia Trial Group. Lancet. 1999 17 354 185-90 6. http://guidance.nice.org.uk/TA83/guidance/pdf/ English 7. Lamb AD, Robson AJ, Nixon SJ. Recurrence after totally extraperitoneal laparoscopic repair: implications for operative technique and surgical training. Surgeon 2006; 4 : 299-307

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