Urological Affections after Laparoscopic Hernia Repair in Long-Term Follow up
Mike Ralf Langenbach, Stefan Sauerland, David Lazica, Hubert Zirngibl
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DOI: 10.4236/ijcm.2011.25100   PDF    HTML     5,523 Downloads   8,795 Views  

Abstract

Objectives: Chronic pain is a severe complication of mesh-based inguinal hernia repair. Pain upon ejaculation, testicular touch sensitivity and dysuria are apparent. Regarding the large amount of patients undergoing laparoscopic hernia repair, the problem seems quite evident. In this prospective, clinical, randomized, double-blind study we intended to investigate the biocompatibility of three different meshes and their influence on urological affections after operative procedure. Methods: 180 male patients with primary inguinal hernia undergoing TAPP were randomized for using a heavyweight (108 g/m2), double-filament PP mesh (Prolene, 10 9 15 cm, group A, n = 60), a multifilament, heavyweight variant (116 g/m2) of PP mesh (Serapren, 10 9 15 cm, group B, n = 60), or a composite mesh (polyglactin and PP) (Vypro II, 10 9 15 cm, group C, n = 60). We compared in terms of complications (seromas, recurrence rate), urological affections and life quality (SF-36 Health Survey). The follow-up period was 60 months. Results: Convalescence in group A was slower than in groups B and C: mean-term values of the visual scales for pain development were significantly (p < 0.05) higher, incapacity for work was 8.2 days longer, and urological adverse effects were stronger. The mean-term development of life quality was significantly lower in group A up to 12th week postoperatively. There were no significant differences between groups B and C. Beyond the 12th post-interventional week the differences diminished. Conclusions: Independent which kind of mesh was implanted still 5% of patients suffered from urological affections 60 month later.

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M. Langenbach, S. Sauerland, D. Lazica and H. Zirngibl, "Urological Affections after Laparoscopic Hernia Repair in Long-Term Follow up," International Journal of Clinical Medicine, Vol. 2 No. 5, 2011, pp. 604-612. doi: 10.4236/ijcm.2011.25100.

1. Introduction

Management with alloplastic materials has become the standard procedure in inguinal hernia surgery [1-4]. Hernia surgery is one of the most common visceral operations and thus of great medical and economic importance. Many publications have shown that there are advantages in the early postoperative outcome and lower recurrence rate when using techniques with mesh implantation compared with mesh-free inguinal hernia repair. Therefore, inguinal hernia repair with mesh has become the standard in the last 20 years. Open surgery according to Lichtenstein was used most often initially, whereas minimally invasive techniques have been increasingly applied in the last decade [1-4]. Chronic pain is the most frequent long-term complication after inguinal hernia repair. Its perceived risk varies widely in the international literature. There are actual studies describing a higher rate of chronic pain after laparoscopic hernia repair in comparison to the open approach and there are studies describing it the other way round. Nevertheless, mesh associated chronic pain after hernia repair is an often described phenomenon [5-7].

Meshes cause rigidity, shrinking, chronic pain, adhesion formation as well as inflammatory process concerning epididimis and vas deferens [8-11]. Permanent relief of pain or discomfort and low incidence of periand postoperative complications and recurrence rates are the goals of successful hernia repair. In laparoscopic inguinal hernia repair the inguinal region is approached and hernia repair is performed from the interior side. Exploration and placement of staplers in the internal inguinal region during laparoscopic hernia repair may induce specific complications such as nerve entrapment, neuralgia, hematomas [12-14]. In laparoscopic procedures mainly polypropylene meshes are used thanks to its strength and incorporation characteristics [13,15,16]. They provoke a strong stimulus for chronic inflammatory response [16- 18]. This problem has led to the development of different meshes characterized by a reduction of the polypropylene volume, an increase of the pore size, different web structures [19,20]. Also meshes with absorbable and nonabsorbable components have been produced and used (filaments of polypropylene and polyglactin) to minimize the amount of non-absorbable foreign material. Although the complications are relatively low considering the large number of meshes being implanted, common complications are observed, including local wound complications, seromas, wound discomfort and stiffness of the abdominal wall [9,13,21-23]. The impact of laparoscopic inguinal hernia repair on open radical retropubic prostatectomy is discussed and it is described that pelvic lympadenectomy could be compromised [24]. How ever, urological affections or disorders do play a leading role in the postoperative disorders like dysuria, touchsensitiveness of the testicle or pain with ejaculation [14].

The designed prospective comparative clinical trial, investigated the compatibility of three different meshes in patients undergoing TAPP for primary inguinal hernia in long-term follow-up. In every case we used the same surgical technique, inserting three different meshes with different polypropylene amount or different structure. We investigated the consequences of reducing the quantity of non-absorbable polypropylene (two pure heavyweight polypropylene meshes, or a polypropylene-polyglactin tangle) and of different structure (doubleand multifilament heavy-weight polypropylene mesh) by means of urological affections and life quality.

2. Methods

180 male patients undergoing an endoscopic hernia repair for primary inguinal hernia with mesh were included (see Figure 1).

After the process of randomisation we had three groups: A: 60 (average age 61.5 years) of these were treated with a monofile, heavy-weight (108 g/m2), double-filament polypropylene mesh. B: 60 (average age 62.3 years) got a multifilament, heavy-weight variant (116 g/m2) of polypropylene mesh being composed by multifile material implanted. C: 60 patients (average age 63.2 years) were treated with a composite-mesh made of polyglactin (PG) and polypropylene (PP) (PP 35 g/m2) (see Table 1).

On the day prior to the operation a detailed physical investigation with determination of the blood routineparameters and a doppler-ultrasound investigation of the testicular vessels (arteria testicularis, plexus pampinifor-

Figure 1. Recruited patients (intention to treat).

Table 1. Mesh data used for TAPP.

mis) took place. The testicle volume and the blood circulation of the testicle were likewise documented at the 1st and 3rd postoperative day by means of ultrasound. At the 1st and 3rd postoperative day as well as after the 1st, 2nd, 4th, 8th and 12th postoperative week and the 12th, 24th and 60th postoperative month on the basis of questionnaires the pain development (visual scales), impairment of the sexual life and duration of incapacity for work were documented. The physical conditions were checked in the 4th, 8th and 12th postoperative week and the 12th, 24th and 60th postoperative month by using the German SF-36 Health Survey Test. This test is an instrument to evaluate the influence on quality of life of different forms of therapies by measuring four components: general physical conditions, social relations, psychological conditions and functional competence. Furthermore postoperative complications were documented.

2.1. Randomisation

The coincidence distribution was done with prepared envelops. The day before the operations every patient has to tear an envelope with a card inside. The name of the mesh was typed on the card. Every surgeon (two fixed teams) received a list with the name of the patient and the sort of mesh that had to be implanted. The surgeons who implanted the mesh were not included in the follow-up. Neither the patients nor the investigating doctor were informed about the type of mesh used (see Table 1).

2.2 Statistical Analysis

Based on our previous experience (Surg. Endosc. 2003; 17:1105-9), our sample size calculation aimed at detecting a difference of 10 points in the SF-36 subscale on bodily pain at the 12-week follow-up. With a power of 80%, a type I error of 5%, and a standard deviation of 18, a sample size of 52 patients per groups was required. Thus, the study recruited a total of 180 patients. Data analysis has been done on an intention to treat basis.

All results are given as mean ±SEM. Differences for parameters obtained at each point of time were evaluated by a 2-way ANOVA for repeated measures using SPSS software. At a level of p < 0.05 differences were considered significant.

The scales of SF-36 have been transformed in values of numbers between 0 and 100 to enable a comparability in each group and the different groups of patients.

2.3. Patients

In the years 1999 - 2001 180 male patients undergoing an endoscopic hernia repair (TAPP) for primary inguinal hernia and fulfilling the criteria were included into the study. After the process of randomisation 60 patients were treated with mesh A, 60 got mesh B and 60 mesh C implanted.

In every group 60 patients were allocated to intervention. In group A only 58 patients received the intervention. In two cases the Lichtenstein procedure had to be done because of massif peritoneal adhesions. Also one person in group B had an operation of Lichtenstein. In group C two patients received open hernia repair because of peritoneal adhesions, like in group A.

Inclusion criteria were: male patient, one-sided inguinal hernia, age between 35 and 75 years, BMI less than 30. The exclusion criteria were: peripheral arterial disease worse than clinical stage II b, recurrent inguinal and scrotal hernia, neurological affections or paresthesia of the genital region or the lateral region of the proximal lower extremity, polyneuropathy, disturbance of the testicular blood circulation with testicular atrophy, therapy with anticoagulative drugs, chronic back pain, intraoperative conversion to open procedures, hydrocele, epididymitis, funiculitis, femoral hernia or incarceration.

Concerning the follow-up we lost two patients in group A after two years: one died and one did house moving. In group B one patient died after one year of follow-up and in group C we lost a patient after two years.

Overall we analysed 58 patients of group A, 59 patients of group B and 58 of group C.

In each group we found COPD, hypercholesterinemia and lipidemia, arterial hypertony and coronary heart disease at comparable percentage (see Table 2). In the

Table 2. Presentation of the three groups undergoing TAPP.

patient group with mesh A we found in 43% a left-sided lateral hernia inguinalis, in 43% a right-sided hernia inguinalis lateralis and in 14% a right-sided hernia inguinalis medialis. In the group with mesh B there were 40% patients with a left-sided hernia inguinalis lateralis, 40% with a right-sided hernia inguinalis lateralis, 10% with a left-sided hernia inguinalis medialis and 10% with a right-sided hernia inguinalis medialis. In group C there were 35% with left-sided hernia inguinalis lateralis, 47% with right-sided hernia inguinalis medialis and 18% with right-sided hernia inguinalis lateralis. The size of the hernia was measured during the operation and the surface was calculated. In all group the surface was determined between 3 and 16 cm2.

2.4. Endoscopic Surgical Procedure

All patients were operated under general anesthesia. At the starting point the pneumoperitoneum was built up with CO2 at 15 mm Hg. A 10 mm trocar was placed within the umbilicus and two 10 mm trocars were placed laterally. The hernia was identified and the peritoneum was dissected. We regularly separated the peritoneum far upwards into the abdominal cavity from the structures of the spermatic cord. In this way we ensured that at final closure of the peritoneum the mesh could not be raised up from its position, lying flat at the inguinal region. Special attention we gave to retrovesical dissection, so that the mesh covered the entire medical compartment without any folds, since this region is predisposed towards recurrences. Depending on the randomisation either mesh A, B or C was positioned. All the meshes had the same size (15 × 10 cm). We did not cut any slits in the meshes. We tried to use a minimum number of clips (Cooper’s ligament, medial and lateral to the epigastric vessels; straight Endostapler, Ethicon, Norderstedt, Germany). Any application of clips between the ductus deferens and testicular vessels (the so called “triangle of domm” with underlying external iliac vessels) and lateral to the structures of the spermatic cord and below the ileopubic tract (the so called “square of doom” with the lateral femoral cutaneous nerve) was strictly avoided. In the case of medial hernias we drew the thinned-out transversalis fascia into the abdomen and fixed it with at least two clips to the ligament of Cooper, to avoid any seroma formation. The hernial sac was always completely dissected out of the hernial canal and separated from the spermatic cord structures. The peritoneum was also closed with an absorbable suture (Ethicon, Vycryl 3/0).

The two surgeons, who carried out the operative procedure, had a training status of laparoscopic hernia repair of more than three hundred.

3. Results

The three groups were comparable in terms of group size and age structure, body mass index and comorbidities as well as the local findings (see Table 2). The overall follow-up rate was 97.2% after 60 months.

The patients spent nearly the same time in hospital (group A: 3.7 days, group B: 3.9 days, group C: 3.8 days). Average operation time was 63.9 minutes in group A, 72.6 minutes in group B and 65.3 minutes in group C. A reduction of the doppler signals in the testicular vessels at the hernia site at preoperative check was found in 8 cases. After surgical therapy the flow was improved. There were no postoperative atrophies of the testicles found. In 10 cases the pampiniform plexus was congested at the site of the hernia. This congestion was relieved in all cases after surgery. In all the groups nearly the same number of complications occurred in the form of scrotal and abdominal wall hematomas, testicular contact pain at the operated site and seroma formation on the 1st and 2nd postoperative days (see Table 3).

We had an overall recurrence rate of 2.3% (two in group A, one in group B and one in group C). In all these cases we found medial recurrences caused by partial mesh migration. There were no significant differences between the individual groups as regards the frequency of recurrence.

From the first postoperative week in all groups an increase of touch-sensitiveness of the testicle at the operated side, pain with ejaculation and discomfort with urination could be documented (see Table 3). These symptoms became significant (p < 0.05) different in the 4th and 12th postoperative week (see Table 3) in group A compared to groups B and C.

Regarding the pain development measured with visual scales one could find significant (p < 0.05) more pain from the 1st day after the operation up to the 12th postoperative week (see Figure 2) in group A.

Figure 2. Pain development after TAPP (p < 0.05).

postop = postoperative.

Table 3. Postoperative complications after TAPP in 180 patients (meshes A, B, C).

In the other groups there was no significant difference in pain development. Nearly the same situation could be found concerning the impairment of sexual life after TAPP through pain. The impairment of sexual life was significantly bigger in group A from the 1st week after the operation up to the 12th postoperative week compared to groups B and C (see Figure 3).

Also the therapy with analgesics (novamine-sulfon drops) reflected the presence of higher pain in group A after the operations. The consummation of the analgesic was significantly (p < 0.05) higher in group A than in groups B and C up to the 4th day after TAPP (see Figure 4).

In group A the average duration of incapacity for work was significantly (p = 0.02) longer (39.1 days) than the one registered in group B (32.4 days) and group C (33.3 days).

Before surgery, the generic quality of life was prospectively measured using the Medical Outcome Study SF-36 Health Survey. In Figure 5 the development of physical function from preoperative upto the 60th postoperative month is shown. At the starting point the average physical function was nearly the same in the three groups. In the 4th postoperative week it was significantly (p < 0.02) lower than in the two other groups.

Figure 6 shows the development of pain measured with the SF-36: One day before the operation pain was nearly the same in all the groups. After the operative procedure up to the 12th postoperative week a significantly stronger pain development was again described in group A than in groups B and C.

Conflicts of Interest

The authors declare no conflicts of interest.

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