Why does NICE not recommend laparoscopic herniorraphy?
BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7345.1092 (Published 04 May 2002) Cite this as: BMJ 2002;324:1092All rapid responses
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The discussion about the NICE decision on laparoscopic surgery for
inguinal hernia is very interesting and, considering that it is over a
year old, indicates the strength of feeling and even confusion around this
issue.
My concern is centred in the economic evaluations which were used to
inform NICE's decision.
An important factor which was not taken into consideration is the
impact on the patient in terms of earlier return to usual activities. If
a patient is able to return to usual activities (such as work) between 6
and 18 days earlier with laparoscopy, as the NICE guidance suggests (1)
there is a potential benefit in earnings of between £340 and £874 (UK
average 2000). The NICE guidance accepts this point (p5, 4.4.1) when it
acknowledges 'The formal introduction of indirect costs significantly
reduces the cost differential between laparoscopic and open repair.'
Despite this acknowledgement this aspect was not considered in the
decision making process or there was an element of misunderstanding of
current best practice in Economic Evaluation.
It is widely accepted within the discipline of Health Economics that
indirect costs should be considered when making decisions on health care
policy (2). This is the 'Societal Perspective' where the costs and the
benefits to patients are carefully considered, in contrast with the 'NHS
Perspective' where the focus can sometimes degenerate towards minimisation
of costs without full consideration of the impact on patients. It is
regrettable that in this case these issues were not fully addressed. We
must remember, however that NICE is gradually developing and learning and
is now much more careful in examining the modelling of the decision.
Additionally, local professionals are interacting in careful
implementation of NICE decisions to influence the improvement of health
care provision (3.
In addition to this serious flaw in the decision modelling it is
apparent that a great deal of the uncertainty in evaluating the costs
arises from the wide differences in customary hospital stay.
We must now wait until August 2003 before this decision is reviewed.
In the meantime the burden will bear most heavily on those who are on the
lowest incomes, who are not eligible for employer sickness benefits, or
the 15% of our population who are self employed with no sickness benefits
whatsoever.
Reference List
1. National Institute for Clinical Excellence. Guidance on the Use
of Laparoscopic Surgery for Inguinal Hernia. Technology Appraisal - No 18.
2001.
2. Drummond M, O'Brien, B., Stoddart, GL, Torrance, GW. Methods for
the Economic Evaluation of Health Care Programs. 1997.
3. Madhok R, Taylor A, Soltani H, Ireland K. NICE and LICE: lessons
from a health district. Journal of Public Health Medicine 2002;24:2-5.
Competing interests: No competing interests
EDITOR- The juxtaposition of Motson’s article1 and the review of
marrow transplantation for breast cancer2 is intriguing. Both refer to
new technologies, strongly supported by interest groups. In the case of
supra-lethal chemotherapy with marrow transplant rescue the evidence has
now been discredited. For the repair of groin hernias the case is not
clear-cut. It is certainly right that patients should be informed of the
laparoscopic option, with its short-term advantages of reduced post-
operative pain and time off work.
However, there is a downside. The review article3 quoted by
Professor Motson includes data on the small risk of ‘potentially serious
complications’, which were more frequent with the laparoscopic operations
in a ratio of 15:4. Informed consent must surely include mention of the
possibly devastating intra-abdominal injuries, even though the incidence
is only of the order of 2.5 per 1000 for laparoscopic compared with 0.25
per 1000 for open hernia repair. Should not the patient then decide
whether the advantages of the laparoscopic operation offset this risk?
Competing interests - none
David Watkin consultant surgeon (retired)
Leicester Royal Infirmary
LE1 5WW
davidwatkin@btinternet.com
1. Motson RW. Why does NICE not recommend laparoscopic herniorraphy?
BMJ 2002; 324:1092-4.
2. Welch HG, Mogielnicki J. Presumed benefit: lessons from the American
experience with marrow transplantation for breast cancer. BMJ 2002; 324:
1088-92.
3. EU Hernia Triallists Collaborative. Laparoscopic compared with open
methods of groin hernia repair: systematic review of randomised controlled
trials. Br J Surg 2000; 87: 860-7.
Competing interests: No competing interests
Editor,
Re Why does NICE not recommend laparoscopic herniorraphy.
Professor Roger Motson disagrees with the recommendation that
laparoscopic herriorraphy has a limited role (1). But he managed to write
the whole article without mentioning the fact that the Lichtenstein open
mesh repair needs only a local anaesthetic (2). Instead he makes the most
odd comment that "if a patient was unfit for general surgery then they
would be limited to open operation under general anaesthetic (sic)". Once
you remove the need for a general anaesthetic open repair is far more cost
-effective.
However even more alarmingly he does not include the use of local
anaesthetic in his section on "telling patients the options". Since local
anaesthesia has manifold advantages this omission is surprising. His final
statement, unsupported by any evidence other than a personal communication
from another laparoscopic enthusiast, implies that "well-informed
patients" will request laparoscopic repair. I could equally-well state
that well-informed patients wish to avoid the expense and morbidity of
general anaesthesia. Both statements reflect only vested interest and
prejudice.
Yours etc,
Alan Cameron, MCh,FRCS,
Consultant Surgeon,
Ipswich Hospital,
IP4 5PD
1; Motson RW. Why does NICE not recommend laparoscopic herniorraphy?
BMJ 2002; 324:1092-4. (4 May).
2; Amid PK, Shulman AG, Lichtenstein IL. The Lichtenstein Open
Tension-free Hernioplasty. In; Arregui ME, Nagan RF,eds.Inguinal Hernias,
advances or controversies. Radcliffe Medical Press, Oxford,
1994, 185-90.
Competing interests.none
Competing interests: No competing interests
Further to my last response --I would like to add the following:
Open mesh repair for primary inguinal hernia is a simple straight forward
procedure with a short learning curve. Results are excellent. WHY find a
complicated solution to a common problem, when we have a simple answer?
Competing interests: No competing interests
Cost effective and value for money procedures without compromising on
safety and quality of care is of paramount importance in the present NHS.
Open mesh repair for primary inguinal hernia can be safely performed under
local anaesthesia in a primary care setting. I have been performing this
procedure for the past seven years with good results. Complication rates
are virtually NIL! Results have been published in national journals of day
surgery. Patients are delighted --as they are operated in a ' patient
friendly familiar environment' --their GP surgery. Patients are given a
choice of operation in a hospital setting or in the primary care setting.
Patients go home in a couple of hours and followed up by a team they know!
Hospital beds, theatre space and time etc.. can be utilised for
complicated procedures requiring a hospital setting. This is one area
where secondary care procedure can be transferred to the primary care --IF
appropriate facilities, protocols and policies are in place and
meticulously adhered. NICE recomendations are appropriate in the present
day NHS.
Competing interests: No competing interests
I read with interest artical by Prof. Motson. The points raised in
response to the guidelines by NICE are very valid and contemporary. I
agree that NICE needs to update the recommendations based on more recently
available evidence. At the same time it is most urgent to point out, that
like other laparoscopic operations, hernia surgery when performed by less
than optimally trained surgeons would result in unsatisfactory outcome.
Secondly, cost of surgery and saving in working days may have entirely
different implications in developing countries or countries with lesser
per capita income compared to U.K.
Also there would be a subset of patients where other medical
conditions may dictate safety for local anaesthesia and in these cases the
indications for laparoscopy should not be stretched.
Competing interests: No competing interests
To the Editor,
I read with interest the paper by RW Motson commenting and criticising the
conclusion of NICE's panel on hernia repair [1]. In France a similar
institute namely the ANAES (Agence Nationale d'Accréditation et
d'Evaluation en Santé) made, in 2000, similar recommendations. Using a
rigorous methodology, the ANAES group [2] concluded that the laparoscopic
approach is feasible, is associated with less postoperative pain and
earlier return to work but lead to specific, potentially severe,
postoperative complications, which is in accordance with those of the main
British trial on laparoscopic herniorrhaphy [3]. The ANAES group included
not less than 10 laparoscopic surgeons.
As a surgeon with a particular interest in Evidence-based surgery, I agree
with both panel's conclusions. Those works were based on systematic
reviews of the literature with an objective assessment of papers and
cannot be suspected of having partisan views. When one looks to the
literature on hernia repair (up to march 2002), not least than 4 meta-
analyses, 3 systematic reviews, and 100 randomized trials (list under
request) allow us to stay only that mesh repair is probably the current
gold-standard, and that the differences between laparoscopy and open mesh
are less significant than those between laparoscopy and non-mesh repair.
Nobody can state now that laparoscopic herniorrhaphy could be considered
as the treatment of choice. In his paper Doctor Motson wrote
'controlateral hernia can be identified and repaired', this imply that
laparoscopy must be conducted by the so-called TAPP (transabdominal
preperitoneal prosthesis), but no trial has showed any advantage of this
approach over the more logical totally extraperitoneal approach (TEP).
Furthermore, several systematic reviews and comparative studies suggested
that the TEP is better than the TAPP in terms of postoperative morbidity
and recurrence. On the other hand, whether a controlateral hernia should
be systematically repaired is highly controversial [4]. There is no sound
evidence to operate such hernias.
Doctor Motson also criticised the cost calculation by NICE. He omitted in
his references list the cost-utility analysis of the MRG group that is
clearly showed that the laparoscopic approach involves a higher cost and
at best may be a viable alternative when reusable equipment is employed
[5]. But is this practical in times when the use of disposable surgical
instruments is highly recommended to avoid iatrogenic transmission of
diseases [6]? Let us tell clearly that laparoscopic herniorrhaphy will
probably remain a procedure involving a high cost. Nice and ANAES did not
tell other than that.
Finally, Dr Motson stated that patients do prefer laparoscopy. Several
University surgical departments in France do not perform laparoscopic
herniorrhaphy because of the lack of evidence regarding its superiority.
French patients (like in UK) are, daily, demanding the laparoscopic
approach, but we have no difficulty ton convince them to undergo an open
mesh. This is true providing that the surgeon is also aware about the
limitations of the procedure. More the surgeon is convinced about the
respective benefits and drawbacks of laparoscopy, easier the patient will
be convinced to undergo the alternative approach.
Fortunately, we have some scientific organisations to evaluate objectively
the emerging procedures. Their conclusions are based on the best available
evidence. When evidence are lacking, the next step is to conduct well-
designed trials to confirm (or invalidate) the hypotheses coming from
expert opinions.
References:
1. Motson RW. Why does NICE not recommend laparoscopic herniorrhaphy? BMJ
2002; 324: 1092-4
2. www.anaes.fr
3. The MRC Laparoscopic Groin Hernia Trial Group. Laparoscopic versus open
repair of groin hernia: a randomised comparison. Lancet 1999; 354: 185-90.
4. Oberlin P. Should every hernia be operated (in French). Ann Chir 2002;
127: 161-3.
5. The MRC Laparoscopic Groin Hernia Trial Group. Cost-utility analysis of
open versus laparoscopic groin hernia repair: results from a multicentre
randomized clinical trial. Br J Surg 2001; 88: 653-61.
6. Frosh A, Joyce R, Johnson A. Iatrogenic vCDJ from surgical instruments.
BMJ 2001; 322: 1558-9.
Karem Slim, Department of Digestive Surgery
Clermont-Ferrand FRANCE
Competing interests: No competing interests
In the education and debate article "Why does NICE not recommend
laparoscopic hernia repair", in respons to the NICE guideline, Motson
correctly cites the evidence that is available up to now. This evidence
tells us that endoscopic hernia repair is as good as the best conventional
repair when recurrence rates are considered. It also tells us that
recovery is quicker and pain is less. Furthermore it tells us that overall
costs (in hospital and thereafter) are the same or even less.
So what then is the problem? There is no evidence that for fit patients
the required general anaesthesia is a drawback. There is also no evidence
that the use of a mesh is harmful (which probably accounts for the
increasing worldwide use of mesh repair in conventional hernia surgery).
The problems are cost and training. The in-hospital costs are higher, but
the community profits from a faster return to work. This should be solved
by reallocation of funds. The other problem, the technique that is still
considered difficult, is more a matter of training than of the technique
itself. If all trainers would start teaching their residents the
endoscopic technique as early as they do with the conventional repair, the
residents will become equally familiar with either techniques.
We should not deny our patients a good opereation, nor should we deny our
residents the training in it.
Competing interests: No competing interests
Sir,
I agree that laparoscopic herniorraphy should be discussed with
patients requiring surgery for primary inguinal herniae, but I feel that
some of Professor Motson`s criticisms of NICE guidelines on hernia
repair(1) are harsh.
Many patients undergoing hernia repair have significant comorbidity and
for some surgery under local anaesthesia may be preferable, but
laparoscopic herniorraphy requires general anaesthesia.
Professor Motson objects to the fact that NICE took oral evidence `from
just one surgical expert`, but expert opinion is the lowest grade of
clinical evidence. Surely a surgeon with an interest in hernia surgery is
more likely to be biased by his own experience than other health
professionals. Modern systematic reviews adhere to rigid protocols hence I
do not see how the inclusion of only one surgeon in the NICE appraisal
panel could have influenced the review.
NICE reviewed the economics of hernia repair from a secondary health care
perspective or, in other words, from the point of view of the hospitals.
It may well be that the social cost of laparoscopic herniorraphy is lower
than for open mesh repair. However, social security and employers` costs
are not charged to the NHS. I may sound cynical, but a saving of £335 per
patient on 100,000 operations/year equates to £33,500,000/year, not a
negligible sum at a time when the NHS is counting its pennies.
To my knowledge, there is no evidence to suggest that repairing occult
contralateral herniae benefits patients. Both laparoscopic and open
herniorraphy are associated with morbidity, particularly chronic pain. It
remains to be seen whether surgery at the preclinical stage is worth the
risk of potentially debilitating sequelae. Repairing occult herniae would
also increase theatre time, a major determinant of treatment cost,
especially in day case surgery.
Open mesh repair is safe and effective even in the hands of trainees(2),
and is quickly learnt. In contrast, laparoscopic herniorraphy has a long
learning curve during which complications and recurrences are common(3).
Comparative studies on laparoscopic herniorraphy are performed by surgeons
familiar with the technique, but not all hernia surgeons have such
expertise. To officially recommend laparoscopic herniorraphy now may
result either in a large number of operations being performed by poorly
trained surgeons, or by a massive waiting list for those who are
recognised experts.
Clinical guidelines are regularly updated. Laparoscopic herniorrhaphy may
well replace open mesh repair soon, as costs of laparoscopic equipment
decrease and laparoscopic expertise becomes widely available. At present
however there are plenty of good reasons why open mesh repair should
remain the standard treatment of primary inguinal herniae.
1- Motson RW. Why does NICE not recommend laparoscopic herniorraphy?
BMJ 2002;324:1092-4
2- Danielsson P, Isacson S, Hansen MV. Randomised study of
Lichtenstein compared with Shouldice inguinal hernia repair by surgeons in
training. Eur J Surg 1999;165:49-53
3- Edwards CC, Bailey RW. Laparoscopic hernia repair: the learning
curve. Surg Laparosc Endosc Percutan Tech 2000;10:149-53
Competing interests: No competing interests
Laparoscopic Hernioplasty is gold standard for recurrent and bilateral inguinal hernia?
Editor - The continuing unabated debates on the role of laparoscopic
hernioplasty/herniorraphy in the management of inguinal hernia is well
examplified
by the NICE recommendations(1) and the subsequent comments by several
authors in
this journal (2). Despite the multitudes of randomized controlled
trials(RCT), the
advantages of laparoscopic hernioplasty over the open tension-free repair
are at best
marginal, based on the studied outcome measures. Truely, this is exactly
the expected
results of any RCT. One wonders the reasons for the inertia in accepting
the findings
of the RCTs by the surgical fraternity, albeit marginal, as justifications
to wider
applications of laparoscopic hernioplasty.
Being a benign, developmental or rather “degenerative” pathology
which is easily
curable by simple surgical manouvre, the outcome measures are
understandably
confined to a few quantifiable mundane parameters like the degree of
postoperative
wound pain, the needs of analgesia and early return to work which are
economic as
much as health in implications. These advantages are nonetheless easily
negated by
the overall economic aspects of herniorraphy as a routine treatment to be
applicable
to the whole community. Macroeconomics of health care takes precedence
over
microeconomic considerations(-individual patients) for a common condition
such as
hernia(and perhaps to a similar degree acute appendicitis) to be
recommended a
certain form of routine therapy by the administrative authority and
professionals alike.
The more important outcome measure ie. therapeutic efficacy are equal for
the two
procedures.However, from the available evidence thus far, special subsets
of inguinal
hernia namely; recurrent and bilateral are perhaps the most suitable
indications for
laparoscopic hernioplasty(3).
It is quite perplexing to learn that NICE recommended laparoscopic
hernioplasty is
the total extraperitoneal procedure(TEP) instead of transabdominal
preperitoneal
counterpart(TAPP) having indicated the two subsets of inguinal hernia
mentioned
above. TEP entails unilateral dissection to repair the preoperatively
diagnosed
ipsilateral hernia. The sub-clinical contralateral hernia will not be
understandably
diagnosed by such a unilateral approach. Whereas, by default, TAPP is
always a
routinely bilateral procedure insofar as inguinal regions are concerned
without any
dissection involved. Furthermore, dissection in the recurrent hernia could
be
troublesome from dense adhesions putting the involved structures at risk
of iatrogenic
injury. Dissecting under clear direct vision in TAPP is theoritically
safer than a
confined space of TEP. TAPP has also been shown to be able to repair the
recurrent
hernia following TEP failure(3).
The current apparent impasse with regard to the exact role of
laparoscopic
hernioplasty has only caused confusions if they were to be exposed to
patients in the
manner suggested during preoperative counselling for consent(1). Perhaps
it is easier
for patients to decide based on the recommendation by NICE with regard to
the stated
indications for laparoscopic hernioplasty.
References
1. Motson R. Why does NICE not recommend laparoscopic herniorraphy?
BMJ 2002;324:1092-1094 ( 4 May )
2. Watkin, D., Cameron, A., Slim, K. (2002). Why does NICE not recommend
laparoscopic herniorraphy?. BMJ 325: 339-339
3. Frankum CE, Ramshaw BJ, White J, Duncan TD, Wilson RA, Mason EM, Lucas
G, Promes J. Laparoscopic repair of bilateral and recurrent hernias. Am
Surg 1999 Sep 65:839-42; discussion 842-3
Competing interests: No competing interests