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. 1999 Jan 16;318(7177):189.

Laparoscopic versus open mesh repair of inguinal hernia

For most patients hernias provoke minimal symptoms

M J Notaras 1
PMCID: PMC1114668  PMID: 9888922

Editor—In Wellwood et al’s trial of laparoscopic hernia repair versus open mesh repair only patients fit for general anaesthesia were preselected.1 We do not know if the rejected patients were suitable for local anaesthesia, which is usually ideal for frail and elderly patients and those with high American Society of Anesthesiologists grades.

The type of anaesthesia used greatly affects morbidity associated with elective hernia repair.2 As the authors report, after laparoscopic repair with general anaesthesia, patients may have postoperative nausea, vomiting, and retention of urine. Disorientation and cognitive dysfunction may occur with elderly patients after general anaesthesia but are rare after local anaesthesia.

In Wellwood et al’s trial postoperative discomfort after laparoscopic repair was reduced slightly, but does it matter? Assessment of postoperative pain is difficult, but elderly patients commonly experience less pain and require less analgesia than young adults after open hernia repair. This might be attributed to the loss of neurones with ageing3 combined with the decrease in muscle bulk. Although laparoscopic repair is more expensive, many people have suggested that there are economic benefits of early return to work. In reality this is not so: patients over 60 are unlikely to be engaged in the labour market, so there is minimal benefit. For elderly patients, who represent half of most series, whether laparoscopic repair offers any benefits at all remains to be proved. Even with rapid recovery most employees expect a traditional amount of time off, whereas self employed patients tend to return to work as soon as possible despite any slight discomfort. The ability and desire to return to work are subjective and greatly influenced by personal circumstances.

Laparoscopic repair is a more complex invasive procedure, and catastrophic complications may occur4; these are unheard of with open repair. In a statistical sense the non-occurrence of an adverse event in a surgical series, as reported in this trial, does not mean that it cannot happen. Major complications from the pneumoperitoneum, bowel and vascular perforation, and acute and delayed intestinal obstruction do occur.

For most patients a hernia is a benign lump that provokes minimal symptoms. Why expose patients to the major risks of a laparoscopic approach when there are marginal differences in outcome compared with open mesh repair under local anaesthesia, especially when open mesh repair is technically simple, is easily learnt, has consistent results, and is safer and cost effective?

References

  • 1.Wellwood J, Sculpher MJ, Stoker D, Nicholls GJ, Geddes C, Whitehead C, et al. Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost. BMJ. 1998;317:1003–1010. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
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BMJ. 1999 Jan 16;318(7177):189.

Recurrence rate is true test of hernia repair

Keith Rose 1, David Wright 1, Charles McCollum 1

Editor—The conclusion that Wellwood et al draw from their randomised controlled trial of laparoscopic versus open mesh repair of inguinal hernia is incomplete.1-1 The authors are to be congratulated on the absence of any major complications from 200 laparoscopic repairs. Would this result be achieved in general surgical procedures, where more severe complications are a feature of most published series?1-2–1-4

Surprisingly, their complication rates for the open tension free mesh repair were unacceptably high. In our series of 200 consecutive open repairs reviewed at two years we found a wound infection rate of only 1% and no cases of testicular atrophy. It is perhaps misleading to include bruising (a minor inconvenience) as though it were as important as severe groin swelling (haematoma?). Similarly, local numbness in a wound after open repair hardly equates with urinary retention after laparoscopic repair.

Figure 3 reports the key results on return to normal activity. Unilateral open repair gives the best results, if only marginally. The prolonged recovery after simultaneous bilateral repair is an argument for sequential repair, which is our policy. Obviously, individual patients express their own preferences.

With differences in recovery being at best marginal, the true test of hernia repair is the recurrence rate. In our series of open repairs there were no recurrences at two years, and in 500 subsequent repairs there have been only three recurrences, all within six months. It is doubtful that the more complex laparoscopic repair can be justified on the data presented. We will be interested to see the results at one and five years.

References

  • 1-1.Wellwood J, Schulpher M, Stoker D, Nicholls G, Geddes G, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair of inguinal hernia: outcome and cost. BMJ. 1998;317:103–110. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
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BMJ. 1999 Jan 16;318(7177):189.

Laparoscopic repair is good when undertaken by experienced surgeons

A E Kark 1, M N Kurzer 1, P A Belsham 1

Editor—Wellwood et al’s report of their trial of laparoscopic versus open mesh repair of inguinal hernia is important as much for what is not said as for what is.2-1

This was a selective randomised study: patients deemed unfit for general anaesthesia were excluded. The number in this group is not given and would include those with serious cardiac or pulmonary disease, the very group most suitable for local anaesthesia. This study thus compares two operations performed on a select group of relatively healthy patients, which produces a bias in favour of laparoscopic repair.

The inclusion of recurrent hernias (roughly 10% in each group) is not helpful. Recurrent hernias are a separate entity, with differing anatomy, sites, and complications. Recurrences after laparoscopic repair require open repair, and open repair often requires preperitoneal abdominal repair.

The short term benefit of laparoscopic repair in terms of postoperative pain is well recognised. However, a fifth of our patients having tension free mesh repairs experienced almost no pain and needed no postoperative analgesia.2-2 Furthermore, the study does not distinguish between younger and older groups, older patients having considerably less pain.

The time of return to work shows sedentary workers resuming in 10 days and active workers in 17 days. This is at variance with our experience of 3175 open repairs,2-3 in which the median time of return to work for office workers was 7 days and for active workers 14 days (this further reduced to 8 days in the past two years).

The rate of sepsis in the open group was 11%; the authors do not distinguish between minor superficial and more important deep sepsis. They do not comment on the effect of prophylactic antibiotics in the 41% of open repairs. The authors make considerable omissions in their estimates of cost. Additional staff are required when general anaesthesia is used, which adds substantially to the cost of laparoscopic repair.

In conclusion, this trial confirms that laparoscopic repair of groin hernia is a good operation when undertaken by experienced laparoscopists in healthy patients, but the incidence of serious visceral or vascular injury, widely reported, cannot be overlooked in less experienced hands.

References

  • 2-1.Wellwood J, Sculpher MJ, Stoker D, Nicholls GJ, Geddes C, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost. BMJ. 1998;317:103–110. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 2-2.Kark AK, Kurzer MN, Waters KT. Tension-free mesh hernia repair: review of 1098 cases using local anaesthesia in a day unit. Ann R Coll Surg Engl. 1995;77:299–304. [PMC free article] [PubMed] [Google Scholar]
  • 2-3.Kark AK, Kurzer MN, Belsham PA. Three thousand one hundred seventy-five primary inguinal hernia repairs: advantages of ambulatory open mesh repair using local anaesthesia. J Am Coll Surg. 1998;186:447–455. doi: 10.1016/s1072-7515(98)00057-x. [DOI] [PubMed] [Google Scholar]
BMJ. 1999 Jan 16;318(7177):189.

Laparoscopic repair can be made less expensive

R S Taylor 1, A Naseef 1, E Brandt 1, S Jacob 1

Editor—The paper by Wellwood et al confirms the opinion of most open minded surgeons with experience of both laparoscopic and open hernia repair.3-1 The results are similar to those of our ongoing trial at St George’s Hospital comparing an entirely extraperitoneal approach with an open mesh repair. We believe that the extraperitoneal approach is superior to the transperitoneal one, although the learning curve is considerably longer.

We question the need to use disposable equipment, which resulted in the laparoscopic repair being more expensive than the open repair. The well documented risks of stapling can be readily avoided by using sutures. If fixation of the patch is thought to be necessary this requires only one or at most two sutures for accurate placement, and the peritoneal incision can be sutured easily in the same time that it takes to staple and at minimal cost. This also eliminates the requirement for a 12 mm port. Likewise, the use of fully disposable scissors is unnecessary. Elimination of these additional costs makes the cost of the two procedures similar; if the ability of patients having laparoscopic repair to return earlier to all normal activities is also taken into account, laparoscopic repair becomes the least expensive procedure.

References

  • 3-1.Wellwood J, Sculpher MJ, Stoker D, Nicholls GJ, Geddes C, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost. BMJ. 1998;317:103–110. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ. 1999 Jan 16;318(7177):189.

Unblinded trials may not be more reliable than observational studies

Ani Anyanwu 1,2, Dermot O’Riordan 1,2

Editor—Wellwood et al’s study highlights difficulties in undertaking randomised trials in surgery.4-1 Two consultants and five trainees performed the operations. The operating skills of the two groups may have differed. Trainees performed fewer procedures and were slower at laparoscopic operations; this may reflect their expertise, ease with the procedure, or previous volume of cases performed. Supervising trainees in five laparoscopic procedures before they undertake trial operations may not be sufficient to ensure a standardised approach by all operators. It would have been interesting to know how many laparoscopic procedures each trainee actually performed.

The duration of bilateral open repair operations was not, as might be expected, twice that of unilateral open repairs but 1.4 times. Interoperator variability in surgical technique may mean that patients did not receive the same standard intervention. The authors did not state if the operator was designated before or after randomisation. It might have been more appropriate to restrict operators to experienced consultants.

Inability to blind surgeons, patients, and assessors is also a problem in many surgical trials. Blinding is a key feature of clinical trials4-2; without it, clinical enthusiasm (or scepticism) may bias interventions and assessment—a possibility in this study as most outcome measures were based on decisions or subjective assessments by doctors, a nurse, or patients. Partial blinding in another laparoscopic trial (of cholecystectomy4-3) failed to show expected early differences, which suggests that postoperative management and patients’ perception are influenced by knowledge of the procedure.

Another difficulty in surgical trials is defining an appropriate end point. Although the sample size was based on use of analgesics and return to normal activity, over 50 statistical comparisons were made between the groups, which makes it difficult for readers to make their own conclusions. The longer term results will be more helpful, as short term benefits become relevant only if laparoscopic surgery does achieve low recurrence rates.4-4 The authors comment on cost effectiveness without presenting actual cost effectiveness data. Judgments on cost effectiveness cannot be made as their costs were not linked to any outcome; this is a necessary step in cost effectiveness analysis and probably reflects difficulty in defining an appropriate outcome.

Unblinded surgical trials are fraught with bias, particularly if they use subjective outcomes assessed by the doctor or patient. We accept the need for more clinical trials in surgery,4-5 but unblinded trials may not eliminate bias encountered when non-randomised controls are used and will not necessarily provide more reliable data than well conducted observational studies.

References

  • 4-1.Wellwood J, Schulpher M, Stoker D, Nicholls G, Geddes G, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair of inguinal hernia: outcome and cost. BMJ. 1998;317:103–110. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4-2.Bradford Hill A. The clinical trial. Br Med Bull. 1951;7:278–282. doi: 10.1093/oxfordjournals.bmb.a073919. [DOI] [PubMed] [Google Scholar]
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  • 4-4.Rutkow IM. The recurrence rate in hernia surgery: how important is it? Arch Surg. 1995;130:575–576. doi: 10.1001/archsurg.1995.01430060013001. [DOI] [PubMed] [Google Scholar]
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BMJ. 1999 Jan 16;318(7177):189.

Costs and outcomes should always be presented in disaggregated form

D P Kernick 1, Deborah Reinhold 1

Editor—Wellwood et al’s study relates the outcomes of two types of repair for inguinal hernia to the resources that were used.5-1 The authors omitted a crucial part of the overall picture and in doing so showed an important point that should be considered when economic analyses are undertaken.

Although from a societal perspective the costing of wage and non-wage time remains controversial to the patient and hence the general practitioner, this element is important. In many cases in this study these costs will probably be greater than the stated NHS costs as one of the greatest differences between the two procedures is likely to be the time taken to return to work. Unfortunately, this simple outcome is not recorded and the adoption of a narrow NHS viewpoint precludes the calculation of both societal and individual perspectives.

Costs and outcomes should always be presented in disaggregated form so that all stakeholders can analyse the data from their individual perspectives.

References

  • 5-1.Wellwood J, Schulpher M, Stoker D, Nicholls G, Geddes G, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair of inguinal hernia: outcome and cost. BMJ. 1998;317:103–110. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]
BMJ. 1999 Jan 16;318(7177):189.

Laparoscopic repair is much more expensive

A G Johnson 1

Editor—The results of Wellwood et al’s prospective randomised trial of laparoscopic versus open mesh repair for inguinal hernia6-1 depend on one’s emphasis. The authors conclude that “laparoscopic hernia repair has considerable short term clinical advantages after discharge, although it was more expensive.” It could also be stated that laparoscopic hernia repair has some short term clinical advantage but is considerably more expensive. An extra £335 per operation would add many millions to the NHS bill, and even if this sum was reduced to £100 per operation it would still have considerable financial implications because the operation is so common.

Perhaps patients could be offered the mesh repair free but be asked to pay a supplement if they would like it done laparoscopically.

References

  • 6-1.Wellwood J, Schulpher M, Stoker D, Nicholls G, Geddes G, Whitehead A, et al. Randomised controlled trial of laparoscopic versus open mesh repair of inguinal hernia: outcome and cost. BMJ. 1998;317:103–110. doi: 10.1136/bmj.317.7151.103. . (11 July.) [DOI] [PMC free article] [PubMed] [Google Scholar]

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