Objective
Objective:
The objective is to clarify the place within European surgical practice of two novel approaches to inguinal hernia repair by performing a systematic review, including meta-analysis, of data from randomised trials. Tension-free open and laparoscopic techniques will be compared with conventional open methods, in respect of clinical effectiveness, particularly freedom from long-term pain and hernia recurrence, and health economics outcomes.
Brief Description:
Repair of inguinal hernia is performed over half a million times each year in Europe. The standard method changed little over the 100 years up to the late 1980s: conventional, open repair relies on tension on the suture line to close the defect and avoid recurrence. Recently, there have been two revolutionary developments in surgical methods. The first is 'tension-free' open repair, associated with the name of Lichtenstein, and the second is the use of minimal access, laparoscopic techniques. Both appear to have short-term advantages, but their cost-effectiveness and long-term clinical performance is uncertain. Evaluative evidence will be most reliable if it is derived from randomised controlled trials in which the surgeon's approach has been chosen by random assignment. Within Europe, at least 35 such trials are either underway or recently completed and it is these which are the focus of this project. The aim is to synthesise data from all these studies using meta-analysis to provide much clearer evidence of effects than the individual trials alone. The project will do this by: increasing precision; improving generalisability; examining sub-groups; exploring the effects of 'minor' modifications in surgical technique; and expanding economic analyses.
Completed and ongoing randomised trials of tension-free or laparoscopic inguinal hernia repair will be identified systematically, and surgeons co-ordinating these trials will form a collaborative group within the concerted action. A statistical secretariat will be established in Aberdeen by the co-ordinator. A common protocol will be agreed by participants and this will define a minimum data set. Data from the trials will be sent to the statistical secretariat and contributed to statistical and economics analyses. A report agreed by all participants will be widely disseminated at the end of the project.
Keywords:
Randomised controlled trial, meta-analysis, inguinal hernia, surgery, economic analysis, health technology assessment, clinical effectiveness, cost effectiveness.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine surgery
- social sciences economics and business economics health economics
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Coordinator
AB25 2ZD ABERDEEN
United Kingdom
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.