IDEAL is a framework for evaluations of surgical innovations, which follow a distinct development pathway differing from the approach developed for pharmacological interventions. Many pathway and evaluation challenges are shared by other interventional therapies, requiring individual therapist skills and customisation of treatment to the individual, partly through medical devices. This paper provides an overview of the IDEAL framework and recommendations, and focuses on the first two stages: idea and development. Surgical innovations comprise new techniques, modified strategies, or innovative instruments. The evidence base for many of these approaches—and therefore for much of current surgical practice—is vastly weaker than for most modern drug treatments. Randomised trials of surgical techniques (versus placebo surgery)1 were conducted within 10 years of the publication of the epochal streptomycin drug trial.2 Yet, despite rapid growth in recent years, the overall number of randomised controlled trials and systematic reviews in surgical innovations remains small compared with the number of studies evaluating drug treatments. Randomised trials have also been few in number and of poor quality in some other therapeutic specialities, where the success of the intervention depends on the skill and judgment of the individual operator.3 The IDEAL Collaboration was born out of a series of conferences between surgeons and methodologists at Balliol College, Oxford,4 5 6 which was convened to study why high quality trials in surgery were genuinely difficult to conduct, and what could be done to improve the evidence base for surgery. The conclusion was that innovation in surgery inevitably follows a pathway with important differences from that followed by pharmacological developments, and that a different approach to evaluation is therefore needed. It was noted that many non-surgical disciplines had similar problems with evaluation of such treatments (termed as “interventional therapies”), which rely on operator skill and tailoring of the …

Blinding is a measure in randomized controlled trials (RCT) to reduce detection and performance bias. There is evidence that lack of blinding leads to overestimated treatment effects. Because of the physical component of interventions, blinding is not easily applicable in surgical trials. This is a protocol for a systematic review and empirical study about actual impact on outcomes and future potential of blinding in general and abdominal surgery RCT. A systematic literature search in CENTRAL, MEDLINE and Web of Science will be conducted to locate RCT between 1996 and 2015 with a surgical intervention. General study characteristics and information on blinding methods will be extracted. The risk of performance and detection bias will be rated as low, unclear or high according to the Cochrane Collaboration’s tool for assessing risk of bias. The main outcome of interest will be the association of a high risk of performance or detection bias with significant trial results and will be tested at a level of significance of 5 %. Further, trials will be meta-analysed in a Mantel-Haenszel model comparing trials with high risk of bias to other trials at a level of significance of 5 %. Detection and performance bias distort treatment effects. The degree of such bias in general and abdominal surgery is unknown. Evidence on influence of missing blinding would improve critical appraisal and conduct of general and abdominal surgery RCT. PROSPERO 2015: CRD42015026837 .

Background: Systematic reviews are an important tool of evidence-based surgery. Surgical systematic reviews and trials, however, require a special methodological approach. Purpose: This article provides recommendations for conducting state-of-the-art systematic reviews in surgery with or without meta-analysis. Conclusions: For systematic reviews in surgery, MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) should be searched. Critical appraisal is at the core of every surgical systematic review, with information on blinding, industry involvement, surgical experience, and standardisation of surgical technique holding special importance. Due to clinical heterogeneity among surgical trials, the random-effects model should be used as a default. In the experience of the Study Center of the German Society of Surgery, adherence to these recommendations yields high-quality surgical systematic reviews.

Background: Development of incisional hernia after open abdominal surgery remains a major cause of post-operative morbidity. The aim of this study was to determine the current practice of surgeons in terms of access to and closure of the abdominal cavity in elective open surgery.Methods: Twelve surgical departments of the INSECT-Trial group documented the following variables for 50 consecutive patients undergoing abdominal surgery: fascial closure techniques, applied suture materials, application of subcutaneous sutures, subcutaneous drains, methods for skin closure. Descriptive analysis was performed and consensus of treatment variables was categorized into four levels: Strong consensus >95%, consensus 75–95%, overall agreement 50–75%, no consensus <50%.Results: 157 out of 599 patients were eligible for analysis (85 (54%) midline, 54 (35%) transverse incisions). After midline incisions the fascia was closed continuously in 55 patients (65%), using slowly absorbable (n = 47, 55%), braided (n = 32, 38%) sutures with a strength of 1 (n = 48, 57%). In the transverse setting the fascia was closed continuously in 39 patients (72%) with slowly absorbable (n = 22, 41%) braided sutures (n = 27, 50%) with a strength of 1 (n = 30, 56%).Conclusion: In the present evaluation midline incision was the most frequently applied access in elective open abdominal surgery. None of the treatments for abdominal wall closure (except skin closure in the midline group) is performed on a consensus level.