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Prospective randomised controlled trial of laparoscopic versus open inguinal hernia mesh repair

 

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

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.

 

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.

Tags: hernia mesh, hernia mesh patch