Prospective randomised controlled trial of laparoscopic versus open inguinal hernia mesh repair
M Douek, G Smith, A Oshowo, D L Stoker, J M Wellwood
Laparoscopy enables hernial orifices to be observed and
tension-free mesh repair to be carried out effectively. In
the first randomised controlled trial on hernia repair,
which compared laparoscopic transabdominal preperitoneal
(TAPP) mesh with open darn repairs, laparoscopic
repair was less painful and enabled patients to
return to work and normal activity more quickly.
1 Since2 3 More4
We present results of a randomised controlled trial
of inguinal hernia repair with over five years
comparing laparoscopic TAPP mesh repair with Lichtenstein
open mesh repair. The main long term objective
of this study was to compare the complication rates
of these procedures.’ follow up,
Participants, methods, and results
We conducted the trial at Whipps Cross and North
Middlesex University Hospitals between May 1995 and
December 1996. The trial design has been reported.5
A total of 403 patients were randomised to one of the
two arms: open repair under local anaesthetic or
laparoscopic TAPP repair under general anaesthetic.
We investigated the long term complication rate and
the incidence of wound numbness, groin pain, testicular
pain, testicular atrophy, contralateral hernias, and
recurrence.
Patients were recalled after a minimum of five
years. One of three independent junior surgeons who
were not involved in the original study (MD, GS, AO)
assessed and clinically examined the patients. We used
a questionnaire that included standard questions that
have been previously validated.5
Of 400 patients included in the final analysis, 374
were alive five years after the operation. A total of 242
patients (65%) were reviewed (120 open repair; 122
laparoscopic repair). Mean follow up was 5.8 years. The
long term complication rate for all reviewed patients
was lower in the TAPP group than in the open mesh
repair group (table). Permanent paraesthesia and groin
pain were significantly reduced in the laparoscopic
group. Of 27 patients with paraesthesia, clinically
important paraesthesia (affecting the patient moderately
or severely) was seen in 12 (44%) in the open
mesh repair group and none in the TAPP group.
Severe pain (pain analogue scores over 50%) on movement
(four patients) or at rest (two patients) was seen
only in patients who underwent open repair. No
serious laparoscopic complications were seen.
Comment
Laparoscopic and Lichtenstein open mesh repairs
were associated with good long term results and a low
incidence of recurrence, but laparoscopic repair
caused less groin pain and permanent paraesthesia
than Lichtenstein mesh repair. With the introduction
of Lichtenstein mesh repair, recurrence rates have
fallen dramatically to below 2%, and therefore
potential long term complications such as pain,
paraesthesia, and testicular atrophy are now more
clinically important than before because they are
mostly irreversible.
NICE recommended that open mesh should be the
preferred surgical procedure for the repair of primary
inguinal hernias and that laparoscopic hernia repair
using the extraperitoneal approach (TEP) should be
considered for repairing recurrent and bilateral
hernias. An increase in the low risk of potentially serious
intraoperative complications, which we have not
seen in our trials, has been reported in association with
the TAPP repair.
the TAPP rather than TEP approach. Clearly, before we
can draw any firm conclusions on the appropriate
laparoscopic technique, long term results of large randomised
studies to compare TAPP with TEP are
required. Until then, it is best to take the pragmatic
approach and use the technique that a centre is most
familiar with.2 Most of the trials to date have used
We thank S Senn (Department of Epidemiology, University College
London) for statistical advice, and R Sims (North Middlesex
University Hospital) and S Mahmood (Whipps Cross University
Hospital) for secretarial support.
Contributors: MD set up the five year review, reviewed patients,
analysed and interpreted the data, drafted the paper, and
obtained funding. GS reviewed patients and assisted with data
analysis. AO assisted with setting up the five year review,
reviewed patients, and assisted with data analysis and writing of
the paper.JMW and DLS were responsible for the study concept
and design, contributed all the patients, performed most of the
operations, supervised the study, contributed to writing the
paper, and will act as guarantors. DLS obtained additional funding
for the study.
Funding: Frank Taylor Memorial Trust and NHS Research and
Development grants.
Competing interests: None declared.
1 Stoker DL, Spiegelhalter DJ, Singh R,Wellwood JM. Laparoscopic versus
open inguinal hernia repair: randomised prospective trial.Lancet
1994;343:1243-5.
2 Collaboration EH. Laparoscopic compared with open methods of groin
hernia repair: systematic review of randomized controlled trials.Br J Surg
2000;87:860-7.
3 Repair of groin hernia with synthetic mesh: meta-analysis of randomized
controlled trials.
4 National Institute for Clinical Excellence.
laparoscopic surgery for inguinal hernia
5 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.Ann Surg 2002;235:322-32.Guidance on the use of. London: NICE, 2001.BMJ 1998;317:103-10.
then, several randomised controlled studies and systematic
reviews have largely confirmed these results.
recently in the United Kingdom, the National Institute
for Clinical Excellence reviewed the available early
results and published its guidance on the use of laparoscopic
surgery for inguinal hernias.