Flow diagram of converted repairs. PHS indicates Prolene Hernia System (Ethicon Inc, Somerville, NJ); MPR, mesh plug repair; and L, Lichtenstein technique.
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Nienhuijs S, Kortmann B, Boerma M, Strobbe L, Rosman C. Preferred Mesh-Based Inguinal Hernia Repair in a Teaching Setting: Results of a Randomized Study. Arch Surg. 2004;139(10):1097–1100. doi:10.1001/archsurg.139.10.1097
Surgeons' preferences for any of 3 methods of inguinal hernia repair are comparable in terms of operating time, incision length, perceived difficulty, and surgeon's satisfaction.
Randomized patient-blinded study.
A total of 334 patients randomized to receive 1 of the 3 repairs.
Patients underwent hernia repair with the Prolene Hernia System, mesh plug repair, or Lichtenstein technique.
Main Outcome Measures
Operating variables, surgeon's rating of satisfaction and difficulty, grade and experience of the operating team, and complications.
The Lichtenstein technique took significantly the longest operating time (52 minutes vs 41 or 42 minutes; P<.001). The mesh plug repair scored the best results in difficulty and satisfaction. Overall, surgeons having performed more than 5 procedures rated the repairs less difficult and with significantly more satisfaction (P<.001 and P = .001, respectively). The complication rate did not differ between the treatment groups. None of the operative findings was correlated to the outcome, except for adverse correlation with the body mass index.
From a surgeon's point of view, the mesh plug repair is superior to the Lichtenstein technique and the Prolene Hernia System in terms of operating time, incision length, perceived difficulty, and surgeon's satisfaction.
Inguinal hernia is a common condition. Its repair is one of the most frequently performed operations in general surgery and, as such, even minor alterations in outcome have an appreciable impact. Such an alteration has been seen in the recurrence rates. The methods that omit the use of a prosthesis are used less frequently, as they have been shown to have significantly more recurrences.1 For the anterior approach, different variations of mesh-based repair have been developed. These variations are increasingly the subject of studies focusing on postoperative pain, as the importance of pain is becoming more prominent.2,3
However, pain might not be the only determinant for choosing the appropriate technique. The ease of handling also plays a role. First, if a procedure requires less dissection through simple placement, it might reduce postoperative pain. Second, a simple technique is convenient in view of the huge number of repairs performed annually. Third, hernia repair is probably one of the first procedures a surgeon in training performs. Teaching aspects are important as they determine the learning curve, eg, the long learning curve is frequently mentioned as a disadvantage of the laparoscopic approach.
The widely used Lichtenstein technique (L), the Prolene Hernia System (PHS) (Ethicon Inc, Somerville, NJ), and mesh plug repair (MPR) are commonly used in open inguinal hernia repair. In the teaching setting, it is highly advisable to limit the availability of mesh-based repairs. For that purpose, a patient-blinded, randomized controlled trial between these mesh-based repairs was designed. The aim was to sound out surgeons' preferences. This report focuses on the reasoning behind the surgeons' choice of one particular mesh-based repair.
Patients 18 years or older with unilateral inguinal hernia were eligible for the study. Exclusion criteria were failure to consent to randomization and recurrent hernia. The study was approved by the local research and ethics committee. A total of 334 patients were randomized between April 1, 2001, and March 31, 2003, to receive a hernia repair with the PHS, MPR, or L. Randomization was done by sealed envelope with computer-generated random allotment. The patients were provided with a detailed information leaflet but were blinded to the type of technique they would receive. After the operation, the patients were discharged when ambulatory. Most stayed less than 24 hours in the hospital. No restrictions of mobility or exercises were given.
Data were collected according to standardized preprinted forms. Collected data were divided into information on the patients, the hernia, the operation, the operating team, and the outcome. Data on the patients included age, male-female ratio, and body mass index. Information on the hernia related to the anatomy and the size of the defect (classified according to the Aachen classification4). The distribution of these data between the groups is shown in Table 1.
The operative findings, including duration of the operation, length of incision, and the technique of anesthesia, were noted immediately after the procedure was done. The operating team noted their grades and experience and filled out a visual analog scale (VAS) score on difficulty and satisfaction with the technique. The VAS is a 100-mm line with the limits written at the ends, eg, from easy to difficult.
Outcome included perioperative complications, wound infections, and recurrences.
This study was carried out in a single teaching institution, where approximately 300 patients with hernias are treated each year. Operations were performed by staff as well as surgical trainees. Surgeons who had performed more than 5 procedures were considered experienced. At least 1 member of the operating team had to have such experience.
The L operation was performed as described by Amid et al.5 A 6 × 11-cm polypropylene mesh (Prolene; Ethicon Inc) was trimmed to match the size of the inguinal floor if necessary. A nonabsorbable suture (3-0 polypropylene) was used caudally and an absorbable suture (3-0 polyglactin) was used cranially to secure the mesh. The MPR operation was performed as described by Robbins and Rutkow.6 The inserted plug (Perfix; Davol Inc, Murray Hill, NJ) was fixed with interrupted absorbable sutures (3-0 polyglactin). For both direct and indirect hernia, the flat mesh was placed sutureless on the anterior surface of the posterior wall. Lateral to the spermatic cord, the split section was sutured. For the technique of the PHS, the preperitoneal space was opened. The circular mesh was placed beneath and the flat mesh above the transversalis fascia. The superficial part was fixed cranially, caudally, and medially with absorbable sutures (3-0 polyglactin). As in the L repair, an aperture for the spermatic cord was made in the outer mesh.
According to the standardized protocol, all patients received a nonsteroidal anti-inflammatory drug and a tranquillizer just before the operation. Prophylactic antibiotics were not used. Surgeons were instructed to make the incisions as small as possible, as this was an indirect measure of the perceived difficulty of the procedure. If the ilioinguinal, iliohypogastric, or genitofemoral nerves were encountered, they were preserved. The hernia sac was not ligated, unless it was a large scrotal one. If a medial suture was required, it was not placed too deeply, to prevent injury to the periosteum of os pubis. After closure of the external oblique and, if necessary, Scarpa fascia, the skin was closed with a subcuticular absorbable suture (4-0 poliglecaprone 25 [Monocryl; Ethicon Inc]).
The sample size was calculated on the basis of the primary end point of postoperative pain. We estimated that a sample of 108 patients in each group would have 90% power to detect a difference in VAS score on postoperative pain of 10 with a 2-sided test. For demographic and operative data, the independent t test and Pearson χ2 test were used. Wilcoxon signed rank test was used for analysis of the operative findings. Spearman correlations were used in analyzing factors of the surgeons' VAS scores on difficulty and satisfaction. A criterion of P<.05 was used for statistical significance.
The outcomes according to technique used are given in Table 2. The L technique took significantly the longest operating time (P<.001 for both comparisons) from skin to skin. The MPR required a slightly smaller incision (P = .44 compared with PHS and P = .25 compared with L). The operating surgeons regarded the PHS and L as significantly more difficult than the MPR (P<.001 for both comparisons). The overall surgeon satisfaction was significantly greater for the MPR (P<.001 for both comparisons). In addition, a significantly higher score on satisfaction was noted for L compared with PHS (P = .02).
The results in the preceding paragraph reflect the techniques actually performed, including converted techniques. The operating team converted to another method in 13 patients. One patient allocated to the L group received the PHS because of an additional femoral hernia. One operating team regarded the PHS not to be appropriate for a totally insufficient posterior inguinal wall and used the L technique. Eleven times the MPR was preferred to the randomly allocated treatment, 5 in the L group and 6 in the PHS group. Reasons mentioned for this deviation were that the proposed technique was too difficult, the defect was too small, and the surgeon wished to instruct a resident in the MPR technique (Figure 1).
Thirty surgeons were involved: 22 surgeons in training and 8 staff members. If the operating surgeon had experience of less than 5 procedures, L was regarded more difficult than MPR (P = .04). Also, the L took longer to perform (P = .02 compared with MPR and P = .005 compared with PHS). Overall, the surgeons with more than 5 procedures' experience rated the repairs less difficult and were more satisfied (P<.001 and P = .002, respectively). If a staff member was on the operating team, the repair was performed on average 3 minutes faster (P = .051) and a larger incision was used (P = .13) (Table 3).
Two perioperative complications in the PHS group were treated conservatively: 1 patient incurred an accidental lesion of the vas deferens and 1 patient was readmitted on the fourth postoperative day to the hospital because of endocarditis. Other complications are given in Table 4. No significant differences in VAS scores on patients' satisfaction with the treatment they received after 3 months were seen (85 for PHS, 83 for MPR, and 83 for L).
The size of the defect or anatomy of the hernia did not influence the results of the VAS scores on difficulty and surgeon satisfaction with the procedure (Table 5). The higher the body mass index, the longer the operation took (P = .002) and the larger were the incisions made (P = .05). Repairs were regarded as more difficult (P = .004) and less satisfactory (P = .04) with higher body mass index.
In summary, this study prospectively compared the operative aspects of the techniques of L, PHS, and MPR in a teaching setting. The MPR turned out to be significantly superior in scores on difficulty and satisfaction. If an operating team was not satisfied with the allocated technique, MPR was the favorite alternative. Both MPR and PHS took significantly less operating time than L.
This study distinguished itself from other reports by also recording VAS scores on difficulty and satisfaction according to the surgeon. One report on a randomized controlled trial between L and MPR found a 5.6-minute savings in operating time and a smaller incision for MPR compared with L. Moreover, the L group experienced significantly more postoperative complications.7 Comparable outcomes were reported by Bringman et al8 in favor of MPR. In that retrospective study of 1032 hernia repairs, the 2 most frequently used techniques were PHS and MPR.9 Both procedures took approximately the same time to perform (approximately 26 minutes) for surgeons who had at least 5 procedures' experience. Shorter operating times were also noted in a comparative study between PHS and L. The PHS was performed in 4 minutes less and with a similar incision size as that used for L (7.6 and 7.8 cm, respectively).10
This study showed little influence of seniority or experience of the operating team on the operating variables. The assumption that a surgeon can be termed experienced after 5 procedures is rather arbitrary. A higher cutoff point would theoretically result in better outcomes for the experienced ones. Our results emphasized that, according to the operating teams, all 3 mesh-based repairs can be used for all sizes and types of hernia in terms of difficulty and satisfaction. The operating aspects were influenced only by the body mass index. A higher body mass index correlated with worse outcomes.
Yet, there are more aspects of hernia repair from an educational point of view. The evaluation of residents' ability to perform a hernia repair is subject to a mentor's preferences. In a similar way, the surgeon's preference for one repair may affect the view of a surgeon in training. The evolution of teaching of technical skills away from this apprenticeship-based activity toward structured programs should be encouraged.11 In a group of 30 different surgeons and even more different combinations of operating teams, this bias should be minimized.
This study showed the MPR to be more user-friendly than PHS and L, with a comparable complication rate. The outcomes were not related to the surgeon, the anatomy of the hernia, or the defect size. Body mass index had a negative effect on the surgeon's performance. If recurrence and complication rates of these mesh-based repairs remain comparable, this report will be of benefit in choosing the standard in a teaching setting.
Correspondence: Simon Nienhuijs, MD, Canisius-Wilhelmina Hospital, PO Box 9100, 6500 HB Nijmegen, the Netherlands (email@example.com).
Accepted for publication March 16, 2004.