Two randomised and placebo-controlled studies of an oral prostacyclin analogue (Iloprost) in severe leg ischaemia [The Oral Iloprost in severe Leg Ischaemia Study Group]

Two separate studies are described using the same prostacyclin analogue in a similar group of patients. Objectives: to assess the tolerability and efficacy of two dose regimens of oral Iloprost compared with placebo in the treatment of patients with ischaemic ulcers, gangrene or rest pain due to severe arterial disease over a period of 4 weeks (Study A) and one year (Study B). Design: multicentre, placebo controlled, double-blind, randomized prospective studies. Subjects & Methods: 178 (study A) and 624 (study B) patients with trophic skin lesions (ulcers or gangrene) or ischaemic rest pain due to severe arterial disease. To confirm severe arterial disease patients were required to have a systolic ankle Doppler pressure of 70 mmHg or less or a toe systolic Doppler pressure of 50 mmHg or less in one leg.In both studies patients were randomly allocated to three treatment groups: placebo, low dose Iloprost (50\u2013100 g twice a day) or high dose (150\u2013200 g twice a day) In Study A the main outcome measures were tolerability of different doses of Iloprost and death, major amputation, healing of trophic lesions and relief of rest pain at the end of the follow up, which was 5 months after the end of the treatment. In Study B the primary end point was time to major amputation and stroke or death up to 12 months. Secondary pre-defined end points included the combined end point of patients alive without amputation, no trophic skin changes, no rest pain and not on regular analgesics. Results: the proportion of patients who completed the 4-week treatment period in Study A at the intended dose was 58%, 43%, 45% respectively in the placebo, low dose and high dose Iloprost groups. In an intention to treat analysis the proportion of patients who survived without major amputation, ulcers or gangrene and had no rest pain was 11% in the placebo group, 19% in the low dose iloprost group and 28% in the high dose Iloprost group. The pooled Iloprost groups showed a statistically significantly better result than the placebo group (p=0.04), as did the high dose Iloprost group compared to the placebo (p=0.014). In Study B there was no treatment benefit in terms of a primary end point of amputation and death. However the secondary combined end point of patients who survived without a major amputation, ulcers or gangrene and had no rest pain, nor a need for regular analgesia was favourable for Iloprost, with 18% of patients in the placebo group reaching this optimal secondary end point, compared to 23% in the low dose Iloprost group and 26% in the higher dose Iloprost group (p<0.05). Conclusions: oral Iloprost administered for a year showed no clear benefit in patients with advanced severe leg ischaemia (PAOD III and IV). The results obtained with 4 weeks\u2019 treatment in Study A and in previous trials of intravenous Iloprost could not be reproduce

Randomized clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia

Background: The Shouldice technique is the 'gold standard' of open non-mesh hernia repair. The aim of this study was to compare 5-year recurrence rates after Shouldice and laparoscopic transabdominal preperitoneal patch (TAPP) repair for primary inguinal hernia. Method: Men with a primary unilateral inguinal hernia were randomized to either Shouldice or TAPP operation. An independent observer scored the surgeons' performance. Follow-up comprised clinical examination after 1 year, a questionnaire after 2 and 3 years, and a clinical examination after 5 years. Results: Between February 1993 and March 1996, 1183 patients were included. Nine hundred and twenty patients were followed for 5 years, 454 in the TAPP group and 466 in the Shouldice group. Recurrences were evenly distributed between groups throughout the follow-up period. The cumulative recurrence rate after 5 years was 6.6 per cent in the TAPP group and 6.7 per cent in the Shouldice group. Postoperative pain was a risk factor for recurrence after Shouldice operation but not after TAPP repair. There was a correlation between a low surgeon's performance score and recurrence. Conclusion: The 5-year recurrence rate is acceptable, with no difference between TAPP and Shouldice repair. Poor operative performance resulted in a higher recurrence rate. The TAPP operation represents an excellent alternative for primary inguinal hernia repair

Estudo anatômico da parede anterior do abdome em cadáver e hérnia de Spiegel

OBJETIVO: Tentar correlacionar a hérnia de Spiegel com eventuais alterações anatômicas da parede anterolateral do abdome. Abordar as particularidades do estudo anatômico em cadáver, com destaque aos músculos oblíquo interno, transverso abdominal, aponeurose de Spiegel, linha semilunar e ao aparecimento de hérnias de Spiegel. MÉTODO: A parede anterolateral do abdome foi dissecada em 31 cadáveres frescos do Departamento de Patologia da Santa Casa de Misericórdia de São Paulo, sendo realizada nos dois primeiros cadáveres a dissecção unilateral e nos 29 restantes o estudo bilateral da parede abdominal, completando 60 dissecções. Considerando que operamos no Hospital São Luiz Gonzaga, da Irmandade da Santa Casa de Misericórdia de São Paulo, 13 doentes com 14 hérnias de Spiegel, pudemos correlacionar os elementos clínicos aos estudos anatômicos em cadáver. RESULTADOS: Defeitos encontrados nos músculos e aponeuroses: Oblíquo externo: 4/60 (6,6%) - Oblíquo interno: 6/60 (10%) - Transverso abdominal: 14/60 (23,3%). Disposição dos músculos em forma de feixes de fibras: Oblíquo interno: 10/60 (16,6%) - Transverso abdominal: 12/60 (20%). CONCLUSÕES: As variações anatômicas e os defeitos encontrados, durante as dissecções do oblíquo interno e transverso abdominal, não se acompanharam de hérnias de Spiegel no cadáver, já a gordura pré-peritoneal, dissecando as fibras da aponeurose de Spiegel e oblíquo interno, foi encontrada nas operações e nas dissecções, podendo representar uma relação entre os defeitos musculoaponeuróticos da parede anterolateral do abdome e a hérnia de Spiegel