Inguinal hernia repair – Totally pre-peritoneal laparoscopic approach versus Stoppa operation

Laparoscopic repair of inguinal hernias almost always implies the placement of a reinforcing mesh prosthesis in the pre-peritoneal space , in accordance with the open operation described by Stoppa in 1967.

The laparoscopic route used was the totally pre-peritoneal (TPP) approach which most closely resembles the Stop­pa technique.

Given that it is only the surgical approach that differs, we felt it useful to undertake a prospective randomized study comparing the two techniques.

Type III: Posterior wall defects:

• A- Direct inguinal hernias.
• B- Large indirect inguinal hernias.
• C- Femoral hernias.

Type IV: Recurrent hernias

1. – Inclusion criteria

• Inguinal hernias, direct or indirect hernias (Nyhus III A-III B), primary or recurrent hernias (Nyhus IV), in males greater than 40 years of age.

1. – Exclusion criteria

• Femoral hernias (Nyhus III C), fema­le patients, irreducible or strangulated hernias, recurrent hernias following mesh repair and large inguino-scrotal hernias.
• Contraindications for general anaesthesia and laparoscopy: age greater than 75 years, poor cardio-respiratory status, cirrhosis, coagulopathies (inclu­ding thrombocytopaenia), glaucoma.
• Previous history of lower midline abdominal incision (excluding appen- dicectomies), abdominal wall or groin infections or pelvic irradiation.
• Morbid obesity (BMP > 30).
• Patient refusal.

2-Methods

• – Techniques

a- Stoppa operation .

Extra peritoneal approach via a lower midline incision:

• Dissection of the preperitoneal space from one psoas muscle to the other.
• Placement of a dacron (Ethicon) mesh (30 x 15 cm) with its lower edge slit to allow passage of the spermatic cord.
• Mesh not fixed.

b- “Laparoscopic” repair. Totally prepe­ritoneal approach (TPP) using direct co-inflation of the cave of Retzius via a Veress Needle, and placement through 3 or 4 ports, of one or (in the case of bilateral hernias) two pieces of polypropylene mesh (Ethicon) slit at the lower edge and not fixed: (11 x 6 cm at the start of the study, later 15 x 13 cm, following an early recurrence (in the eleventh patient).

c- Common features.

• General anaesthesia.
• Antibiotic prophylaxis using a 1 g intravenous bolus of Cloxacilline® (Beecham, Nanterre, France) on induc­tion.
• Anti-thrombosis prophylaxis with subcutaneous low molecular weight heparin (Calcium Nadroparine®- Sanofi, Gentilly, France) commenced pre operatively at a dosage of 0.3 ml once a day.
• Preparation of the operative site with chlorhexidine® 0-5% (Zeneca Pharma, Cergy, France).
• Decision to drain left to the discre­tion of the surgeon.
• – Methodology

From July 1991 to March 1995, 100 patients were selected prospectively according to the above criteria. Informed consent was obtained by written agree­ment between the interested parties.

Patients with hernias of Nyhus types

• A, III В, IV were allocated to either of the two operative groups using ran­dom number tables.

Before beginning the study, the laparoscopic (TPP) operation was per­formed on 50 patients, not included in the series. This was to confirm the feasi­bility of the operation and serve as a training period for the four members of the surgical team.

Results were expressed as mean values with standard deviations. The two groups were compared using, the non-parametric Mann-Witney test as well as Chi and Student’s-1 tests.

• – Outcomes for comparison
• Mortality and morbidity: wound infection, urinary infection, lymphangi­tis, general medical conditions.
• Length of operation, hospitalisa­tion and time off work.
• Evaluation of recurrence rates constituted the principal criterion for comparison. All patients were seen at one month by their operating surgeon. Long term follow-up consisted of six monthly reviews by a surgeon indepen­dent of the protocol.
• Evaluation of post operative com­fort.
• Post operative pain was assessed by means of a verbal scale comprising a list of words from which the patient selected one or more to best describe his pain and to which he attributed a coefficient as a function of intensity. The coeffi­cients were then added to give a total score.
• A visual scale, consisting of a line extending from left (no pain) to right (unbearable pain) on which the patient noted the intensity of pain experienced. The distance along the line was thus used to give a score from 0 to 10.
• Analgesic consumption: Paraceta­mol® (UPSA, Rueil Malmaison, France) at a dosage of 1 gram up to 4 times a day was made freely available, thus permit­ting the evaluation of daily consump­tion by each group.

Laparoscopic                        Stoppa

Direct (Nyhus IIIA)                       36                                     39

Indirect (Nyhus IIIB)                     15                                     10

Bilateral                                             21                                     24

Recurrent (Nyhus IV)                   20                                     23

• – Mortality and morbidity

There were no deaths in either group. Morbidity was significantly less after laparoscopic surgery: two cases (4%) versus eleven cases (29.5%) for the open method . In this latter group, five cases were related to the abdominal wall (two wound infections, two haematomas, one dehiscence), three to urinary problems and three to general medical conditions.

• – Length of hospital stay (Table 3)

Regardless of the type of hernia, this was significantly shorter after laparoscopic surgery (3.2 days), repre­senting an improvement of some 60% when compared to the Stoppa opera­tion. In the latter group, the length of stay for patients suffering a complica­tion was indeed longer (8.7 days) but this was not actually significant when compared to uncomplicated cases (7.3 days).

• – Post operative pain

This was significantly greater for patients in the Stoppa group.

• The verbal scale index was three­fold higher with respect to the laparo­scopic group on day one and fourfold on days 2 and 3 .
• The visual scale index was increased threefold on day one, five­fold on day 2 and sixfold on day 3 .
• Paracetamol consumption was also significantly greater in the Stoppa group by factors of 3.1,6 and 20 on days
• and 3 respectively .

These data lead us to conclude that post operative pain and analgesic consumption was less after laparosco­pic surgery. Patients in the Stoppa group experienced more pain, despite greater use of paracetamol. These pain levels were independent of mor­bidity.

• – Return to work

Of the 40 patients in regular employ­ment (28 in office and 12 manual labour), 21 were treated laparoscopically and 19 by the Stoppa operation. Return to work was significantly earlier after laparoscopy (17 ± 11 days vs 35 ± 14 days), regardless of the type of work.

• – Follow-up

The rate of follow up was 97% at one year, 95% at two years, and 93% at three years. The mean duration was compa­rable in both groups (570 days for lapa­roscopy and 610 days for Stoppa) with extremes of 30 and 1600 days.

• – Recurrences

There were three recurrences (6%) in the laparoscopic group and one (2%) in the Stoppa group (ns). The recurrences in the laparoscopic group all occurred at the outset of the study . They were first noted at two, four, seven months respectively and could be attributed in each case to a mesh which was too small (11 x 6 cm, not fixed) and not tailored to the surfa­ce to be covered. Since the routine use of the larger (15 x 12 cm) mesh no fur­ther recurrences have been detected.

The laparoscopic approach to ingui­nal hernias is based on the same prin­ciple. After dissection of the sac and spermatic cord, it is routine to place a mesh in the pre-peritoneal space in order to occlude the deep inguinal ring.

Two basic techniques can be used: The intra peritoneal approach involves the crea­tion of a pneumo-peritoneum with its implicit risks of visceral and vascular injuries related to insufflation and tro­car insertion. It also requires the fixa­tion to Cooper’s ligament of a polypro­pylene mesh which according to those who regularly use this method, should be as large as possible . This technique may result in specific complications related to difficulties in closing the peritoneum , such as incarceration of a loop of small bowel and secondary intestinal lesions caused by adhesion to the prosthesis. Its prin­cipal advantage however is the impro­ved exposure and visualisation of all possible hernia sites. By contrast, the totally pre-peritoneal route most closely resembles the Stoppa technique and would therefore seem to us to be opti­mal. All of its technical aspects have been standardised with the exception of problems relating to parietalisation and mesh fixation. Apart from the cost of automatic staplers, stapling per se may lead to neural and vascular complica­tions and rarely but nonetheless impor­tantly, to pubic osteitis.

Fashioning a slit for the cord as we have described in reproducing Stoppa’s technique effecti­vely anchors the mesh and obviates the need for staple fixation.

Whichever method is used and des­pite the large numbers in some series, long-term follow-up remains inadequa­te for assessment of effectiveness.

Until now few controlled studies have been reported. Although differing widely with regard to the techniques compared they have all tended to pro­duce results in favour of laparoscopic treatment. Post-operative recovery has been shorter and less painful and the resumption of work and leisure activi­ties more rapid.

Kunz in a series of 70 patients, compared the intra-peritoneal laparoscopic method with the Shouldice repair and found the former to have no significant benefit other than impro­ved comfort in the first post operative week and a greater degree of satisfac­tion at one month.

In 1994 we reported the preliminary results of a controlled trial of 181 patients (ongoing study) comparing the totally pre-perito­neal approach to the Shouldice method. Once again there was no apparent diffe­rence between the two groups (even with respect to recurrences at an avera­ge follow up interval of 15 months) other than a better quality of life in the immediate post-operative period.

Stocker’s study of 75 patients compared two groups of patients treated by the intra-peritoneal laparoscopic method and Lichtenstein’s operation . Analgesic consumption was less in the laparosco­pic group despite infiltration of the operative site with Bupivacaine. Resumption of domestic activities was also more rapid (three vs seven days ; p=.ooi) as was return to work (14 vs 28 days ; p= 0.002). Subsequent recurren­ce rates were not mentioned.

Payne performed an identical study with two groups of 45 patients. It was noted that the cost of laparoscopy was greater (+20%) but there were no differences in the other parameters studied Recurrence rates were not evaluated. Vogt with a series of 61 patients com­pared the Mac Vay and Bassini opera­tions with the laparoscopic placement of ePTFE prostheses. There were two conversions out of 31 (6%) and 2 recur­rences (6%) in each group when contacted by telephone at one year.

Barkum performed a randomised controlled trial with two groups of 49 and 43 cases respectively. Once again the laparoscopic groups experienced less post operative pain and had a shorter recovery time. The recurrence rate at 14 months (4 out of 43 or 10%) was comparable for both groups. The methodology of this study could be criticised because of the wide variety of operative techniques employed in the “conventional” group (58% were Shouldice operations, 35% Lichtenstein, and 4.8% Mac Vay, as well as a few “plug” procedures). 75% of the laparoscopic group had a pre peritoneal approach. The experience of the opera­tors and the type of anaesthesia used were also somewhat variable.

Finally, the recent work of Wilson has compared the Lichtenstein operation with the intra-peritoneal laparoscopic approach in a prospective study of 242 patients. The length of ope­ration in both groups was comparable but again the duration of hospital stay was shorter for the laparoscopic group (one vs two days) as was the time to return to work (10 vs 21 days; p=o.ooi). Interestingly there were no apparent differences in post operative comfort and analgesic consumption.

The work we report here is the first to compare two essentially identical opera­tions that differ only in their means of approach (open or laparoscopic) and the type and size of prostheses used.

The nature of dissection of the pre peritoneal space in both operations is exactly the same, albeit somewhat slo­wer by the laparoscopic method, espe­cially in the case of bilateral and/or recurrent hernias .

It must be said that there was a rela­tively high incidence of accidental pneumoperitoneum occuring (27.4%) during dissection of the hernia sac, par­ticularly in the case of recurrent her­nias. This reduces the amount of space for dissection, but is easily controlled by insertion of an intra-peritoneal Verres needle which is left open. In one case only, an obese patient, did this event necessitate conversion.

The conversion rate (6% or three cases) illustrates the limits of the pre peritoneal route: relative obesity and the size of the hernia. This particularly applies to large inguinoscrotal hernias which in other respects represent an ideal indication for the pre-peritoneal approach.

Four features in favour of the lapa­roscopic operation have been demons­trated:

• A significant reduction in the mean length of hospital stay (3.2 vs
• days) which confirms the majority of earlier studies . This could still however be considered relatively long when compared to certain British series . In this regard, Johannet in France has performed this operation on a day surgery basis with good results .

-A significant reduction (4 vs 21.5%; p=0.02) in abdominal wall and urinary pathology.

-Finally, the significant reduction in time off work (17 vs 35 days) in this parti­cular sub-group (40%) accords with data already in the literature .

Recurrence rates are somewhat dif­ficult to evaluate. All our patients were followed up at one year, 95% at two years and 93% at three years. There were three recurrences (6%) all incur­red at the beginning of our experience and presentation at one, two and three years respectively. These appreared to result from insufficient coverage of the hernial defects by meshes that were too small. This was verified by laparoscopy and the patients were then treated by the Lichtenstein operation. No further recurrences were noted after the eleven­th patient in the series, by which time larger prostheses were being employed (15 x 12 cm). After this modification the recurrence rate became identical to that of the Stoppa operation. One patient treated by the open method had a recurrence at 13 months.

Factors leading to recurrence were studied by Deans (1995b) in a series of 10 cases from a total of 800 operations (0.8%) with a mean follow up of 14 months. The basic cause was once again a prosthesis of insufficient size, failing to come into contact with Cooper’s ligament or remaining partial­ly rolled up. The author treated these cases laparoscopically by placement of a second larger mesh.

The size of the prosthetic mesh should be the same whether the hernia be repaired openly or laparoscopically . The direct relationship between mesh size and incidence of recurrence is well established. The cur­rent trend is not only to use prostheses that are as large as possible but also to insert large mono-piece (30 x 12 cm) meshes in bilateral hernias , even though their placement may be somewhat difficult. This so-called “bikini” prosthesis proposed by Dean produced excellent results in a series of 150 cases with a mean operative duration of 43 minutes, a hospital stay of one day, return to work by seven days, and no recurrences in an 18 month follow-up period.

The operative experience of the sur­geon obviously also plays an important role, as seen in our series. Kald confir­med this in 1995 with seven recurrences out of 200 (3.5%) at one year, six of which occurred in the first 31 cases.

On the basis of our results and those of the literature one could confidently assume that, given adequate mastery of the technique (50 cases) and the use of large mono-piece prostheses, as in Stoppa’s original operation, laparosco­py will come to assume increasingly greater importance in the treatment of groin hernias.

Conclusions

Taking into account the inclusion and exclusion criteria of this study, the lapa­roscopic approach would seem prefe­rable to the “classical” Stoppa operation in terms of the post operative quality of life, length of hospital stay and inter­ruption of occupational activity. The higher incidence of recurrence (6%) in the laparoscopic group merely reflects initial operative inexperience and the use of inadequately sized prostheses. The preferential employment of large «mono-ріесе» meshes particularly for bilateral hernias reduces the recurrence rate towards that of open operations. The laparoscopic pre-peritoneal method is thus set to become an accep­ted means of inguinal hernia repair.

Operative outcomes

a- Length of operation: This was com­parable for unilateral hernias but signi­ficantly longer for bilateral and recur­rent types.

b- Intra operative complications:

• In the “Stoppa group” there were two instances (4%) of haemorrhage into the retropubic space.
• In the “laparoscopic group”, there was only one case of bleeding during dissection of the spermatic cord. By contrast, there were 14 cases (77.4%), mainly in recurrent hernias (n=io), where the peritoneum was breached leading to a pneumo-peritoneum. There were three conversions (6%): one in an obese patient, but BMI< 30, ano­ther with large bilateral hernias and a third where a pneumo-peritoneum significantly reduced the field of vision in the pre-peritoneal space. These illus­trate the limitations of the totally pre­peritoneal approach. Suction drainage was necessary in 3 cases following lapa­roscopy and in 7 after the Stoppa opera­tion . The mean duration of drainage was comparable in both groups (2.8 ± 1.7 days).