Quere- versus Längslaparotomie — Eine randomisiert verblindete Studie

Abstract

Background: Transverse incisions in open abdominal surgery may cause less pain than the midline approach according to the results of a recent Systematic Review and Meta-Analysis of the Cochrane Collaboration. Relevant clinical and methodological bias was detected in the underlying studies in addition. Therefore we investigated both incision types in a randomized patient and observer blinded trial. Methods: 200 patients with primary elective laparotomy for major abdominal procedures were randomized either to a midline or transverse incision in this single centre equivalence designed trial. After a standardized wound closure both groups received wound dressings covering the whole abdomen and a similar pain management through a patient controlled pump. Composite primary end point measured 48 hours after surgery was total amount of analgesics (piritramide) required in last 24 hours and pain (Visual Analogue Scale). Secondary end points were early-onset and late complications. Results: 101 patients in the midline and 99 patients in the transverse group were comparable after randomization at baseline for demographic and clinical characteristics. Blinding was successful. The pain medication used was similar in both groups (95 % CI -0.38–0.33). For the VAS the results were neither within the equivalence level (9 % CI 0–10) nor were a significant difference detected between the two incision types at a 5 % level. Only wound infections occurred more often in the transverse group (15 versus 5, p = 0.02) whereas frequencies of all other secondary endpoints (mortality, pulmonary complications, incisional hernias after one year) were not different between the groups. Conclusion: Incisions should be carried out according to the decision of the responsible surgeon focusing on the anatomy and planned intervention.