| Autor: |
Patrick Heger, Manuel Feißt, Johannes Krisam, Christina Klose, Colette Dörr-Harim, Solveig Tenckhoff, Markus W. Büchler, Markus K. Diener, Andre Mihaljevic |
| Rok vydání: |
2019 |
| DOI: |
10.21203/rs.2.13713/v1 |
| Popis: |
Background: Incisional hernias are among the most frequent complications following abdominal surgery and cause substantial morbidity, impaired health-related quality of life and costs. Despite improvements in abdominal wall closure techniques the risk for developing an incisional hernia is reported to be between 10-30% following midline laparotomies. There have been two recent innovations with promising results to reduce hernia risks, namely the small stitches technique and the placement of a prophylactic mesh. So far, these two techniques have not been evaluated in combination. Methods: The HULC trial is a multicentre randomized controlled, observer and patient blinded surgical effectiveness trial with two parallel study groups. A total of 812 patients scheduled for elective abdominal surgery via a midline laparotomy will be randomized in 12 centres after informed consent. Patients will be randomly assigned to the control group receiving closure of the midline incision with a slowly absorbable monofilament suture in small stitches technique or to the intervention group that will receive a small stitches closure followed by augmentation with a light-weight polypropylen mesh in onlay technique. The primary endpoint will be the occurrence of incisional hernias as defined by the European Hernia Society within 24 months after surgery. Further perioperative parameters, as well as patient-reported outcomes, will be analysed as secondary outcomes. Discussion: The HULC trial will address the yet unanswered question whether a combination of small stitched fascial closure and onlay mesh augmentation after elective midline laparotomies reduces the risk of incisional hernias. The HULC trial marks the logical and innovative next step in the development of a safe abdominal closure technique. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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