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The transinguinal preperitoneal (TIPP) technique using a soft mesh with a memory ring was developed recently for inguinal hernia repair. To compare TIPP with the Lichtenstein method, a randomised trial was conducted (ISRCTN93798494). The aim of this study was to perform an economic evaluation of the TIPP modality compared to the Lichtenstein modality from both a hospital and societal perspective alongside the clinical trial. The TULIP study was a double-blind randomised clinical trial comparing two techniques for inguinal hernia repair (TIPP and Lichtenstein). Correct generation of the allocation sequence, allocation concealment, blinding, and follow-up were used/applied according to the recommendations of the Cochrane Handbook. Next to the cost drivers, the short-form-36 health survey (SF-36) data from the TULIP trial was used to determine utility. The SF-36 data from the TULIP trial were revised using the SF-6D algorithm according to Brazier. Two scenarios-a hospital and a societal perspective-were presented. If the analyses showed no difference in effects (on the SF-6D) the cost effectiveness decision rule to cost minimisation was altered. No significant difference in SF-6D utility between both modalities was found (mean difference: 0.888, 95% CI -1.02 to 1.23); consequently, the economic decision rule became cost minimisation. For the hospital perspective no significant differences in costs were found (mean difference: euro -13, 95% CI euro -130 to euro 104). However, when including productivity gains in the analysis, significant differences (P = 0.037) in costs favouring the TIPP modality (mean saving: euro 1,472, 95% CI euro 463- euro 2,714) were found. The results show that TIPP is a cost-saving inguinal hernia repair technique compared to the Lichtenstein modality against equal effectiveness expressed as quality adjusted life week at 1 year given a societal perspective. In the trial, TIPP patients showed on average a quicker recovery of 6.5 days compared to Lichtenstein patients.

Background: The Lichtenstein technique is the treatment of first choice according to guidelines for primary inguinal hernia treatment. Postoperative chronic pain has been reported as complication in 15-40 % after Lichtenstein's repair. The postoperative effects on health status after open preperitoneal hernia repair have hardly been examined. Development of an open technique that combines the safe anterior approach of the Lichtenstein with the 'promising' preperitoneal soft mesh position was done; the transinguinal preperitoneal (TIPP) mesh repair. A double-blind prospective randomized controlled trial (TULIP trial, ISRCTN93798494) was conducted to compare different outcome parameters after TIPP or Lichtenstein, one parameter is topic of evaluation in this paper; the health status after TIPP and Lichtenstein for inguinal hernia repair., Methods: The study protocol has been published. It was hypothesized that the health status of inguinal hernia patients would be better after the TIPP repair compared with the Lichtenstein technique. The size of this study was based on chronic pain as primary outcome measure. Three hundred and two patients were randomized. Patients and the outcome assessors were blinded. Follow-up was scheduled after 14 days, 3 months, and 1 year. The three dimensions of possible errors were warranted., Results: With regard to health status, significant differences were found in the dimensions 'physical pain' [difference: 6.1 (95 % CI 2.3-9.9, p = 0.002)] and 'physical functioning' [difference: 3.5 (95 % CI 0.5-6.7, p = 0.023)], favoring the TIPP patients after 1 year., Conclusion: In conclusion, the SF-36 'physical function' and 'physical pain' dimensions after TIPP show significant better patient outcomes at 1 year compared with the Lichtenstein patients in this trial. These differences are in line with reported significant differences in less patients with postoperative chronic pain after TIPP compared with Lichtenstein at 1 year.

Background: Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair., Methods: The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients' perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure., Trial Registration: Current Controlled Trials: ISRCTN18591339.

Background: Preliminary experience has suggested that preperitoneal mesh positioning causes less chronic pain than Lichtenstein's technique for inguinal hernia repair. Therefore, a randomized clinical trial was conducted with the aim of evaluating the incidence of postoperative chronic pain after transinguinal preperitoneal (TIPP) mesh repair versus Lichtenstein's technique., Methods: Patients with a primary unilateral inguinal hernia were randomized to either TIPP or Lichtenstein's repair in two training hospitals. The primary outcome was the number of patients with chronic pain after surgery. Secondary outcomes were adverse events. Follow-up was scheduled after 14 days, 3 months and 1 year. Patients and outcome assessors were blinded., Results: A total of 302 patients were randomized to TIPP (143) or Lichtenstein (159) repair. Baseline characteristics were comparable in the two groups. Some 98.0 per cent of the patients were included in the analysis (141 in the TIPP group and 155 in the Lichtenstein group). Significantly fewer patients in the TIPP group had continuous chronic pain 1 year after surgery: five patients (3.5 per cent) versus 20 patients (12.9 per cent) in the Lichtenstein group (P = 0.004). An additional 12 patients (8.5 per cent) in the TIPP group and 60 (38.7 per cent) in the Lichtenstein group experienced pain during activity (P = 0.001). There were two patients with recurrence in the TIPP group and four in the Lichtenstein group, but no significant differences were found in other severe adverse events between the groups., Conclusion: Fewer patients had continuous chronic pain at 1 year after the TIPP mesh inguinal hernia repair compared with Lichtenstein's repair., (Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: Chronic pain is the main drawback of the Lichtenstein procedure for inguinal hernia repair, with a reported incidence of 15-40%. The transinguinal pre-peritoneal (TIPP) technique seems to be associated with less chronic pain, comparable to the total extra peritoneal (TEP) technique. The aim of this study was to evaluate 3 years of TIPP and Lichtenstein experience since the start of our Hernia Center Brabant in January 2006., Methods: Patient records of unilateral primary inguinal anterior hernia corrections (TIPP and Lichtenstein) performed since the opening of Hernia Center Brabant (2006-2008) were evaluated in a retrospective study. ASA class 4 and 5, <18 years, recurrences and bilateral hernias were excluded. In the TIPP technique, a Polysoft™ Hernia Patch was placed into the preperitoneal space using an anterior protocol led approach. The Lichtenstein technique was performed as described by Amid [Amid et al (1996) Eur J Surg 162:447-453] and modified with a soft mesh. One of the hernia surgeons decided peroperatively which technique to perform. Baseline characteristics and postoperative complications were assessed retrospectively. The attempted follow up period was 6 months. Chronic pain was assessed in both groups as mild (VAS 1-3), moderate (VAS 4-6) or severe (VAS 7-10). Chronic pain was defined in both groups as any pain sensation lasting longer than 3 months postoperatively, or when local injection of analgesia was necessary. Patients who did not come back because of chronic pain after regular follow up were regarded as free of pain., Results: A total of 496 patients were included in this study; 225 TIPP and 271 Lichtenstein anterior inguinal hernia operations were analyzed. Data from one TIPP-patient were lost. Both groups were comparable with regard to baseline characteristics regarding age (p = 0.059), gender (p = 0.478) and ASA-classification (p = 0.104). TIPP: mean age 52.7 years, ASA-classification I: 54%, II: 36% and III: 5.3%. A total of 7.6% complications were assessed; recurrence (n = 1), bleeding (and re-operation) (n = 4); 10 patients (4.4%) experienced chronic pain. Persisting sensation loss occurred in 0.9%. Lichtenstein: mean age 57.3 years, ASA-classification I: 51%, II: 38% and III: 11%. A total of 8.5% complications were assessed; recurrence (n = 3), bleeding (and re-operation) (n = 3); 11 Lichtenstein patients (4.1%) experienced chronic pain. Persisting sensation loss occurred in 2.2%. Limitations of this retrospective study were incomplete follow up (31.3% had only one post operative visit 14 days after surgery) and these patients were further regarded as free of pain. Therefore, possible under-reporting of chronic pain could be present. The study was not double blind., Conclusion: This retrospective study design revealed no significantly better results for the TIPP procedure as compared to the Lichtenstein technique. The incidence of chronic pain reported in this retrospective study has been low in both groups since the opening of the Hernia Center Brabant. These results form the basis for a prospective randomized clinical trial comparing the TIPP and Lichtenstein techniques.

Background: Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain., Methods: The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work) and recurrence. Both groups will be evaluated.Success rate of hernia repair and complications will be measured as safeguard for quality.To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP) technique reduces postoperative pain to <10%, with alpha = 0,05 and power 80%, a total sample size of 300 patients was calculated., Discussion: The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP) technique, compared to Lichtenstein.In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein., Trial Registration: ISRCTN 93798494.

Background: Surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds. There are several advantages to the use of adhesive bonds compared with the conventional sutures., Methods: Between January and August 2001, all the wounds in children after groin surgery were closed with an adhesive, N-butylcyanoacrylate (Indermil, Locite Corp, 's-Hertogenbosch, The Netherlands), or with a suture, polyglactin 5-0 (Vicryl), intracutaneously. Fifty Inguinal wounds were treated with Indermil and 50 with Vicryl. Wounds were evaluated for hematoma, infection, dehiscence, or formation of granuloma. A scale from 1 to 10 expressed the cosmesis by patient and surgeon., Results: The most remarkable difference in wound healing was dehiscence of the wound in 26% of cases in the adhesive group and no dehiscence in the suture group. The cosmesis of the wounds was marked with an 8.6 in the suture group and in the adhesive group with a 6.8., Conclusions: Wound dehiscence was seen significantly more frequent in the patients in whom the wound was closed with N-butylcyanoacrylate. The cosmesis of wounds closed with tissue glue was significantly lower then the cosmesis after suturing. Therefore, the authors advise, on the basis of this prospective randomized trial, that surgical wounds in children should be closed with a intracutaneous absorbable suture.