Hernia (2007) 11:429–434 DOI 10.1007/s10029-007-0252-1
ORIGINAL ARTICLE
Does the approach to the groin make a difference in hernia repair? ¨ . Gu¨nal Æ S¸. O ¨ zer Æ E. Gu¨rleyik Æ T. Bahc¸ebas¸ı O
Received: 31 August 2006 / Accepted: 18 May 2007 / Published online: 3 July 2007 Springer-Verlag 2007
Abstract Background Laparoscopic and open preperitoneal hernia repair techniques both use the preperitoneal space. This study investigated whether the surgical approach to the inguinal canal affects outcome measures. Methods One hundred sixty patients with inguinal hernia were assigned randomly into open anterior (42), open preperitoneal (39), laparoscopic transabdominal preperitoneal (39), and laparoscopic total extraperitoneal (40) groups according to the surgical method. The peroperative serum tumor necrosis factor-a (TNF-a) levels, interleukin-6 (IL-6) levels, VAS scores at 6 and 48 h, per- and postoperative complications, and recurrence rates were determined as main variables. Results The serum IL-6 levels were 335 ± 1.8, 283 ± 1.8, 283 ± 1.4, and 269.3 ± 1.6 pg/ml in the open anterior, posterior, transabdominal preperitoneal, and total extraperitoneal groups, respectively (P < 0.01). The TNF-a levels were highest in the open anterior group. The pain
¨ .Gu¨nal E. Gu¨rleyik O Department of General Surgery, Medical Faculty, Du¨zce University, Konuralp, Duzce, Turkey T. Bahc¸ebas¸ı Department of Public Medicine and Biostatistics, Medical Faculty, Du¨zce University, Konuralp, Duzce, Turkey ¨ zer S¸.O Department of Surgery, Kasimpasa Naval Hospital, Kasimpasa, Istanbul, Turkey ¨ .Gu¨nal (&) O Hukukcular Sitesi, B1 Blok, Daire 5, Yenilevend, 34330 Istanbul, Turkey e-mail:
[email protected]
scores were lower in groups undergoing the posterior approach than in the open anterior approach group. Conclusion The approach to the inguinal canal through the preperitoneal space appears to be less invasive than the transinguinal anterior approach. Keywords Laparoscopic Inguinal hernia TNF-a IL-6 Preperitoneal
Introduction The prevalence of groin hernia is estimated to be 1.5 or 5% for the Western male population [1, 2]. The best method of treating this common disorder is a controversial issue. Although various surgical techniques have been assessed for effectiveness, the importance of the approach to the inguinal canal has been underestimated. The posterior approach to hernia repair was described in the late 1800s [3]. Since its formal introduction to surgical practice [4], open preperitoneal inguinal hernia repair has not gained acceptance for routine use, although it is usually suggested for recurrent inguinal hernias. Although generally underused, this technique offers an excellent option for the repair of all inguinal hernias, especially incarcerated ones. By combining preperitoneal repair with a laparoscopic technique, a truly novel option for herniorrhaphy was created. The laparoscopic approach to the repair of inguinal hernias was introduced in 1990 [5]. Both laparoscopic techniques used to repair inguinal hernias work through the preperitoneal space, which is the mainstay of the three operations in our study. In many studies, laparoscopic surgery has been advocated as the less invasive surgical technique [6–8]. Laparoscopy offers lower recurrence and postoperative complication rates than standard primary
123
430
open inguinal hernia repair, with the potential for a faster, more comfortable recovery than the ‘‘tension-free’’ open inguinal hernia repair [3]. Whether the work is done in the preperitoneal space may be the factor that determines the invasiveness of the surgical procedure used to repair a given groin hernia. The search for a less invasive, less reactive technique or approach to inguinal hernia repair has continued. The inflammatory process is a vital stress response to injury, infection, trauma, and other insults [9]. Tumor necrosis factor-a (TNF-a) and interleukin-6 (IL-6) are inflammatory mediators that reflect the level of surgical trauma [9, 10]. The optimal technique for the repair of inguinal hernias in the context of inflammatory reactivity is still being debated. Therefore, this prospective study evaluated different approaches to the inguinal canal in inguinal hernia repair, mainly with respect to the inflammatory response, pain, and per- and postoperative complications.
Materials and methods Patients admitted to hospital under the care of two consultant general surgeons between February 1997 and February 2001 were included in the trial. Informed consent was obtained before the operation. The study was approved by the local ethics committee. Patients that have unsatisfactory data or those that could not be reached at their last follow-up call were removed from the study. One hundred sixty patients were randomly assigned to open anterior (AA; n = 42), open posterior (PA; n = 39), laparoscopic transabdominal preperitoneal (TAPP; n = 39), and laparoscopic total extraperitoneal (TEP; n = 40) hernia repair groups. All operations were performed under general anesthesia by two consultant general surgeons who were highly experienced in open and laparoscopic hernia surgery. Inclusion criteria Only low-risk patients with a diagnosis of primary unilateral inguinal hernia were included in the study. Their physical status was either ASA I or II. Based on the intraoperative findings, cases were categorized according to the Nyhus classification [11]. Nyhus type 1, 2, 3A, and 3B patients were included in the study. Technique for the anterior approach A Lichtenstein tension-free hernia repair was accomplished by emplacing a 6 · 12-cm Prolene mesh to the anterior aspect of the posterior wall.
123
Hernia (2007) 11:429–434
Technique for the posterior approach A Nyhus repair was performed by emplacing a 6 · 12-cm Prolene mesh to the posterior aspect of the inguinal defect. TAPP technique Posterior abdominal wall exposure was attained by inserting three trocars into the abdomen following CO2 insufflation. The preperitoneal space was accessed by cutting through the peritoneum with a 15-cm transverse incision that commenced 4 cm lateral to the anterior iliac spine and remained on the pubic tubercle. After exploring the defect in the posterior inguinal wall, a 6 · 12-cm Prolene mesh was fixed to the posterior abdominal wall using a hernia stapler. TEP technique After balloon trocar expansion of the preperitoneal space and CO2 insufflation, three trocars were placed in the space. The defect was repaired with a 6 · 12-cm Prolene mesh that was fixed to the posterior inguinal wall using a hernia stapler. Sample collection and chemical analysis Five milliliters of blood were withdrawn from the antecubital vein during the surgical procedure at the stage of peritoneal handling (during hernia sac preparation or at the moment of hernia sac excision). Serum was separated and stored at –70 C until analysis. Serum IL-6 and TNF-a levels were measured using an enzyme-linked immunosorbent assay method with commercial TNF-a and IL-6 kits (CYTELISATM; CytImmune, College Park, MD, USA). The sensitivities for TNF-a and IL-6 were 18.2 and 16.8 pg/ml, respectively. The duration of the operation (operation time; OT), age, and follow-up time were recorded. Visual analog scale (VAS) scores were measured 6 and 48 h postoperatively. Patients took postoperative parenteral analgesia that kept their VAS scores within reasonable ranges. Per- and postoperative complications and recurrences were also documented. A control study of recurrence of hernia was carried out by phone questionnaire. Patients were contacted by phone at their final follow-up times. They were asked if they had any complaint about their hernia repair or if they had any inguinal bulge. The data are presented as mean ± SEM. The significance of differences between groups was assessed using analysis of variance and Kruskal–Wallis tests. Bonferroni test was used as a post hoc test for intergroup analysis. Spearman’s test was used to identify correlations between
Hernia (2007) 11:429–434
431
the variables in each group. Logistic regression analysis was also performed to investigate whether any relationships existed between approaches and outcome measures. Probabilities of less than 0.05 were considered significant.
Results The TAPP repair was the longest operation in terms of OT, followed by the TEP. The TAPP patients were older than all of the other groups. The mean follow-up time was more than seven years (Table 1). A significant difference was observed in the TNF-a and IL-6 levels among the four groups (Table 2). The VAS scores 6 and 48 h postoperatively also differed significantly among the groups (Table 3). The VAS scores decreased significantly in each group 48 h postoperatively (P < 0.05) when compared to the score at 6 h. However, the VAS was still markedly elevated in the AA group at 48 h (Table 3). Levels of per- and postoperative complications were significantly higher with the anterior approach. The perioperative complications in the AA group consisted of four inferior epigastric vessel bleeds, two pampiniform plexus bleeds, and three ilioinguinal nerve and one ductus deference injuries. Seven, three, and two inferior epigastric vessels bleeds occurred in the PA, TAPP, and TEP repair groups, respectively. In the AA group, the postoperative complications included seven scrotal edemas, one urinary retention, and one hematoma in the penis. One urinary retention and one incisional hematoma occurred in the PA group. We encountered one subcutaneous emphysema and one urinary retention in the TAPP group and one urinary retention in the TEP group. Recurrences seemed to occur more frequently in the AA group, but the difference was not statistically significant (Table 3). Significant correlations were observed between the peroperative IL-6 levels and the peroperative TNF-a levels (r = 0.215, P = 0.006), postoperative VAS scores at 6 h (r = 0.473, P = 0.001) and 48 h (r = 0.336, P = 0.001), and peroperative (r = 0.339, P = 0.001) and postoperative
(r = 0.202, P = 0.01) complications. No correlation was found between TNF-a levels and other outcome measures apart from IL-6. Regression analysis of each factor revealed that IL-6 was significantly affected by the type of approach (P = 0.001, R = 0.768), peroperative TNF-a levels (P = 0.005, R = 0.049), and OT (P = 0.004, R = 0.052). In addition, the peroperative TNF-a levels were significantly affected by OT (P < 0.001, R = 0.078) and the peroperative IL-6 levels (P = 0.003, R = 0.56). The VAS at 6 h was significantly influenced by the type of approach (P < 0.001, R = 0.118) and IL-6 levels (P < 0.001, R = 0.227), and the VAS at 48 h was significantly affected by the type of approach (P < 0.001, R = 0.203), peroperative IL-6 levels (P < 0.001, R = 0.112), and OT (P = 0.002, R = 0.059). Furthermore, the peroperative complications were significantly affected by the type of approach (P = 0.006, R = 0.047), and the postoperative complications were significantly influenced by the type of approach (P = 0.017, R = 0.036) and peroperative IL-6 levels (P = 0.011, R = 0.041). The postoperative 6-h VAS score was likely the only factor that affected the recurrence rate (P = 0.001, R = 0.064).
Discussion To date, the most important criterion for comparing different repair techniques has been the recurrence rate. As primary repair through an AA gave way to the ‘‘tensionfree’’ Lichtenstein technique in the latter part of the twentieth century, hernia recurrence rates fell dramatically. With this fall in recurrence rates, other postoperative factors became measures of herniorrhaphy technique quality. Reductions in postoperative pain and recovery time have become the basis for comparing techniques. The inflammatory response induced by various approaches to the inguinal area is one of the decisive measures that determines the invasiveness of the procedure. Takahara et al. reported a considerable inflammatory response in both
Table 1 Mean patient age, duration of surgery, and follow-up time AA
PA
Age (years)
22.76 ± 0.3
23.85 ± 0.49
OT (minute)
39.64 ± 1.28
36.54 ± 1.55
FUT (months)
97.71 ± 0.79
99.00 ± 0.70
TAPP 25.72 ± 1.09 104.49 ± 8.1 87.59 ± 2.77
TEP
F-valuea
P-value
22.38 ± 0.65
4.76
0.003
57.37 ± 3.84
47.67
<0.001
87.20 ± 1.1
16.67
<0.001
AA anterior approach, PA posterior approach, TAPP transabdominal preperitoneal, TEP total extraperitoneal, OT operation time, FUT follow-up time Bonferroni test P-values: age: AA–PA = 1, AA–TAPP = 0.0001, AA–TEP = 0.033, PA–TAPP = 0.0001, PA–TEP = 0.009, TEP–TAPP = 0.000; OT: AA–PA = 1, AA–TAPP = 0.015, AA–TEP = 1, PA-TAPP = 0.345, PA–TEP = 0.794, TEP–TAPP = 0.005; FUP: AA–PA = 1, AA–TAPP = 0.0001, AA–TEP = 0.0001, PA–TAPP = 0.0001, PA–TEP = 0.0001, TEP–TAPP = 1 a
One-way ANOVA
123
432
Hernia (2007) 11:429–434
Table 2 Peroperative serum IL-6 and TNF-a levels Cytokine type
AA
PA
TAPP
TEP
F-valuea
P-value
IL-6 level (pg/ml)
335.3 ± 1.8
283.6 ± 1.8
283.9 ± 1.4
269.3 ± 1.6
304.19
<0.001
TNF-a level (pg/ml)
132.7 ± 1.1
132.1 ± 1.9
137.9 ± 1.3
130.5 ± 1.6
4.43
0.005
AA open anterior approach, PA open posterior approach, TAPP transabdominal preperitoneal, TEP total extraperitoneal Bonferroni test P-values: IL-6: AA–PA = 0.0001, AA–TAPP = 0.0001, AA–TEP = 0.0001, PA–TAPP = 1, PA–TEP = 0.0001, TAPP–TEP = 0.0001; TNF-a: AA–PA = 1, AA–TAPP = 1, AA–TEP = 1, PA–TAPP = 0.049, PA–TEP = 1, TAPP–TEP = 0.004 a
One-way ANOVA
Table 3 Clinical outcome measures Outcome measures
AA n = 42
PA n = 39
TAPP n = 39
TEP n = 40
P-value
6h
7.3 ± 1.6
6 ± 1.4
6 ± 1.4
5.5 ± 1.2
F = 12.754a
P < 0.001
48 h
4.8 ± 1.4
3.7 ± 1
3.25 ± 1
3.3 ± 1.2
F = 14.460a
P < 0.001
VAS (mm)
2
b
Per-operative complications (%)
10 (23.8)
7 (17.9)
3 (7.7)
2 (5.0)
v = 7.903
P = 0.048
Postoperative complications (%)
9 (21.4)
2 (5.1)
2 (5.1)
3 (7.5)
v2 = 8.377b
P = 0.039
Recurrences (%)
3 (7.1)
1 (2.6)
1 (2.6)
0
–b
P > 0.05
AA open anterior approach, PA open posterior approach, TAPP transabdominal preperitoneal, TEP total extraperitoneal Bonferroni test P-values: VAS 6 h: AA–PA = 0.001, AA–TAPP = 0.0001, AA–TEP = 0.0001, PA–TAPP = 1, PA–TEP = 0.33, TAPP–TEP = 0.756; VAS 48 h: AA–PA = 0.001, AA–TAPP = 0.0001, AA–TEP = 0.0001, PA–TAPP = 0.477, PA–TEP = 0.647, TAPP–TEP = 1 a
One-way ANOVA
b
Kruskal–Wallis test
open and laparoscopic surgical procedures for inguinal hernia [12]. Laboratory evaluation of the inflammatory response to surgical injury has provided an objective approach to determining the magnitude of stress caused by a surgical procedure [13, 14]. Surgical injury induces an inflammatory response that is generally stimulated by a group of host proteins called cytokines. IL-6 and TNF-a play the main roles in the acute phase of the inflammatory response [9, 15]. The serum IL-6 level begins to increase just after the incision, reaches a peak 8–24 h postoperatively, and returns to the preoperative level at 48–72 h in patients without early complications [13–15]. TNF-a release in response to acute injury is rapid and short-lived. Experiments using endotoxin in humans have demonstrated that TNF-a levels peak approximately 90 min after the injection and return to undetectable levels within 4 h. Due to the short-lived response characteristics of both cytokines, we measured the immediate cytokine response at the time of maximal surgical stress as that reached during hernia sac preparation. Hernia sac dissection or preparation is also the farthest point of dissection in AA hernia repair. In contrast to many studies that have measured the cytokine levels at different times postoperatively, we used the peroperative levels of both cytokines as a marker of the inflammatory response. The postoperative inflammatory response might be affected not only by the surgical procedure itself, but also by
123
the prosthesis implanted during the operation. In recent years, the use of prosthetic material has become established in groin herniorrhaphy [16]. The presence of prosthetic material itself might contribute to the inflammatory response of the technique used. Although it was not statistically significant, Gu¨rleyik et al. found higher IL-6 levels in patients with an open mesh repair than in patients with an open conventional repair [10]. Di Vita et al. suggested that polypropylene mesh is an inducer that is responsible for the higher IL-6 levels in laparoscopic hernia repair despite its lower pain scores and more rapid postoperative recovery compared with open Bassini repair [17]. We applied similarly sized Prolene mesh in all groups considering the role of prosthetic material as a stimulant for cytokine release. Therefore, we do not believe that it made a difference among the groups in our study. The postoperative cytokine response to laparoscopic and open hernia repair has been compared as an outcome measure in some studies [18–20]. The findings, however, are controversial, with some reports asserting that open surgical repair (Shouldice) is less inflammatory than laparoscopic repair [18]; others suggesting that open repair, even tension-free repair, induces more inflammation [20]; and yet others reporting no difference between open and laparoscopic hernia repairs with respect to the cytokine response to surgery [21, 22]. In our study, the IL-6 levels were significantly elevated in the AA group compared to
Hernia (2007) 11:429–434
the other groups. We observed the same IL-6 response in the PA and TAPP groups, and the TNF-a level was the highest in the TAPP group. However, the TNF-a responses in the AA, PA, and TEP groups were similar. TAPP repair seems to cause a higher IL-6 response. Jess et al. observed similar cytokine responses in their study groups [19], reporting a higher IL-6 level in the open repair group and the same TNF-a levels in the open and laparoscopic repair groups. Pain causes corticosteroid release from the adrenal cortex and adrenaline discharge from the medulla, and corticosteroids accelerate leukocyte migration, while simultaneously inhibiting TNF-a release. Even with a halflife of 15–18 min, the brief appearance of TNF-a can induce different effects [9, 23, 24]. TNF-a also causes IL-6 release from macrophages and leukocytes [13], which may have boosted the IL-6 release seen in the AA group. This cytokine response may have been attributable to the depth of anesthesia. The AA group required more dissection before reaching the peritoneal sac, which may have caused greater IL-6 release. However, we did not observe any concomitant TNF-a level alteration in relation to this pain effect. We could not explain this different cytokine response to the AA repair, except by invoking this mechanism. The elevation of the TNF-a levels in the TAPP group might have been related to the longer OT. In support of this finding, we determined that the OT was the prominent factor affecting the perioperative TNF-a levels: a longer OT led to greater stress. Paganini et al. found no significant differences among the VAS scores given by patients 6 h postoperatively between the open ‘‘tension-free’’ anterior inguinal hernia repair and laparoscopic transabdominal preperitoneal hernia repair techniques [25]. However, they observed greater pain perception and increased analgesic consumption in the open repair group at 48 h postoperatively. Although we did not consider the analgesic requirement, the VAS scores differed significantly among all the groups at both 6 and 48 h. In our study, the AA group had the maximum pain scores at both times. TEP repair resulted in the best pain scores at both times. Kald et al. reported that the patients in their series expressed extreme satisfaction with TEP repair in terms of postoperative pain [6]. The per- and postoperative complications were higher in the AA group compared to the other groups. More recurrences were observed in the AA group, although the difference was not statistically significant. When we searched for a correlation between IL-6 and outcome measures using Spearman’s test, we found positive correlations with the TNF-a levels, postoperative pain scores, and per- and postoperative complications. No correlation was observed between the TNF-a level and other outcome measures. Regression analysis showed that the approach chosen for
433
the repair of the inguinal hernia might have an effect on the peroperative IL-6 levels (P = 0.001, R = 0.768). However, there were quite weak relationships between the type of approach and peroperative (P = 0.006, R = 0.047) or postoperative (P = 0.017, R = 0.036) complications. No statistical difference was detected between the groups in terms of recurrence, which was likely to be affected only by the VAS score 6 h postoperatively. The data obtained in this study revealed that laparoscopic and open hernia repair techniques induce different types of cytokine responses in the repair of inguinal hernia. While the IL-6 levels increased markedly in AA, the TAPP technique caused a greater elevation in the TNF-a level than the other approaches. From the perspective of cytokine responses, pain scores, and per- and postoperative complications, the techniques using the preperitoneal approach to the inguinal canal seemed to be less invasive. Although it is performed as an open procedure, the posterior approach is likely the determining factor in the invasiveness of inguinal hernia repair. A PA inguinal hernia repair can be used as a routine procedure for the repair of inguinal hernias. References 1. US Department of Health, Education and Welfare (1960) National health survey on hernias (December, Series B, No. 25). US Government Printing Office, Washington, DC 2. Zimmerman IM, Anson BJ (1967) The anatomy and surgery of hernia. Lippincott Williams & Wilkins, Baltimore, MD 3. Klaristenfeld DD, Mahoney E, Iannitti DA (2005) Minimally invasive tension-free inguinal hernia repair. Surg Technol Int 14:157–163 4. Patino JF, Garcia Herreros LG, Zundel N (1998) Inguinal hernia repair. The Nyhus posterior preperitoneal operation. Surg Clin North Am 78:1063–1074 5. Ger R, Monroe K, Duvivier R, Mishrick A (1990) Management of indirect inguinal hernias by laparoscopic closure of the neck of the sac. Am J Surg 159:370–373 6. Kald A, Smedh K, Anderberg B (1995) Laparoscopic groin hernia repair: results of 200 consecutive cases. Br J Surg 82:618–620 7. McKernan JB, Laws HL (1993) Laparoscopic repair of inguinal hernias using a totally extraperitoneal prosthetic approach. Surg Endosc 7:26–28 8. Spivak H, Nudelman I, Fuco V, Rubin M, Raz P, Peri A, Lelcuk S, Eidelman LA (1999) Laparoscopic extraperitoneal inguinal hernia repair with spinal anesthesia and nitrous oxide insufflation. Surg Endosc 13:1026–1029 9. Ward PA, Lentsch AB (1999) Acute inflammatory response and its regulation. Arch Surg 134:666–669 ¨ nalmiser S (1998) The 10. Gu¨rleyik E, Gu¨rleyik G, C¸etinkaya F, U inflammatory response to open tension-free inguinal hernioplasty versus conventional repairs. Am J Surg 175:179–182 11. Nyhus LM, Pollack R, Bruceck CT (1988) The preperitoneal approach and prosthetic buttress repair for recurrent hernia. Ann Surg 208:783 12. Takahara T, Uyama I, Ogiwara H (1995) Inflammatory responses in open versus laparoscopic herniorrhaphy. J Laparoendosc Surg 5:317–326
123
434 13. Baigrie RJ, Lamont PM, Kwiatkowsky D (1992) Systemic cytokine response after major surgery. Br J Surg 79:757–760 14. Ohzato H, Yoshizaki K, Nishimoto N (1992) Interleukin-6 as a new indicator of inflammatory status: detection of serum levels of interleukin-6 and C-reactive protein after surgery. Surgery 111:201–209 15. Biffl WE, Moore EE, Moore FA, Peterson VM (1996) Interleukin-6 in the injured patient. Marker of injury or mediator of inflammation? Ann Surg 224:647–664 16. Goyal S, Abbasakoor F, Stephenson BM (1999) Experience with the preperitoneal ‘‘plug and patch’’ inguinal hernia repair. Br J Surg 86:1284–1285 17. Di Vita G, Milano S, Frazzetta M, Patti R, Palazzolo V, Barbera C, Ferlazzo V, Leo P, Cillari E (2000) Tension-free hernia repair is associated with an increase in inflammatory response markers against the mesh. Am J Surg 180:203–207 18. Schwab R, Eissele S, Bruckner UB, Gebhard F, Becker HP (2004) Systemic inflammatory response after endoscopic (TEP) vs. Shouldice groin hernia repair. Hernia 8:226–232 19. Jess P, Schultz K, Bendtzen K, Nielsen OH (2000) Systemic inflammatory responses during laparoscopic and open inguinal
123
Hernia (2007) 11:429–434
20.
21.
22.
23.
24. 25.
hernia repair: a randomised prospective study. Eur J Surg 16:540–544 Akhtar K, Kamalky-asl ID, Lamb WR, Laing I, Walton L, Pearson RC, Parrott NR (1998) Metabolic and inflammatory responses after laparoscopic and open inguinal hernia repair. Ann R Coll Surg Engl 80:125–130 Schrenk P, Bettelheim P, Woisetschlager R, Rieger R, Wayand WU (1996) Metabolic responses after laparoscopic or open hernia repair. Surg Endosc 10:628–632 Hill AD, Banwell PE, Darzi A, Menzies-Gow N, Monson JR, Guillou PJ (1995) Inflammatory markers following laparoscopic and open hernia repair. Surg Endosc 9:695–698 Cinat ME, Waxman K (1994) Trauma causes sustained elevation of soluble tumor necrosis factor receptors. J Am Coll Surg 179:529–532 Enayati P, Brennan MF (1994) Systemic and liver cytokine activation. Arch Surg 129:1159–1165 Paganini AM, Lezoche E, Carle F (1998) A randomized, controlled, clinical study of laparoscopic versus open tension-free inguinal hernia repair. Surg Endosc 12:979–986