https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61116-8.pdf

No surgical innovation without evaluation: the IDEAL recommendations.

Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists. Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.

/pdf/consort-statement-for-randomized-trials-of-nonpharmacologic-4uqflkox34.pdf

CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61083-7.pdf

Evaluation and stages of surgical innovations.

Objective To assess the impact of postoperative complications on full in-hospital costs per case. Background Rising expenses for complex medical procedures combined with constrained resources represent a major challenge. The severity of postoperative complications reflects surgical outcomes. The magnitude of the cost created by negative outcomes is unclear. Patients and methods Morbidity of 1200 consecutive patients undergoing major surgery from 2005 to 2008 in a tertiary, high-volume center was assessed by a validated, complication score system. Full in-hospital costs were collected for each patient. Statistical analysis was performed using a multivariate linear regression model adjusted for potential confounders. Results This study population included 393 complex liver/bile duct surgeries, 110 major pancreas operations, 389 colon resections, and 308 Roux-en-Y gastric bypasses. The overall 30-day mortality rate was 1.8%, whereas morbidity was 53.8%. Patients with an uneventful course had mean costs per case of US$ 27,946 (SD US$ 15,106). Costs increased dramatically with the severity of postoperative complications and reached the mean costs of US$ 159,345 (SD US$ 151,191) for grade IV complications. This increase in costs, up to 5 times the cost of a similar operation without complications, was observed for all types of investigated procedures, although the magnitude of the increase varied, with the highest costs in patients undergoing pancreas surgery. Conclusion This study demonstrates the dramatic impact of postoperative complications on full in-hospital costs per case and that complications are the strongest indicator of costs. Furthermore, the study highlights a relevant savings capacity for major surgical procedures, and supports all efforts to lower negative events in the postoperative course.

The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients.

opital Paul Brousse in Paris, France, with the introduction of sequential operations, referred to as “2-stage hepatectomy” to stepwise remove multiple liver tumors, with the aim of allowing the liver to regenerate between both procedures 4 Additional PVE was also used in a few patients Soon after, Daniel Jaeck and his colleagues from Strasbourg, France, developed another 2-stage approach for bilateral (predominantly right) tumor involvement Using routine right PVE, after the initial removal of tumors located in the left hemiliver, the resulting hypertrophy of the left part of the liver (free of tumor) allowed a safer curative right or extended-right hemihepatectomy 5 Finally, the group from Zurich modified this approach by applying concomitant right portal vein ligation with wedge resections of all left-sided tumors during the first surgery, followed a few weeks later by an extended righthepatectomy 1 Thismodificationwasbasedonevidencethatportalveinligationtriggersasimilar or better regenerative response than PVE 6,7 and could be safely applied, even in combination with partial hepatectomies of the left hemiliver In a few patients with intact primary neuroendocrine or colorectal tumors, Belghiti and colleagues have also used portal vein ligation along with resection of the primary tumor 8 In many patients, those developments led to the successful removal of multiple, often bilateral, liver lesions otherwise felt to be unresectable The drawback, however, was the need for long intervals between the 2 surgeries The earlier techniques, without the use of selective portal vein occlusion, required a delay of 2 to 13 months before completing the second hepatectomy 4 The majority of patients in whom this approach failed, did so because they had developed disease progression in the meantime 4 With the advent of PVE, this period was dramatically shortened to 2 to 4 months, 5 and with concomitant portal vein ligature to about 4 weeks 1 Other shortcomings included the insufficient hypertrophy of a putative remnant liver, preventing curative resection or, if performed, leading to postoperative failure due to “small for size” syndrome 3 In Figure 1, we show the development of the various types of staged hepatectomies The article in this issue of Annals of Surgery by Schnitzbauer and coworkers call out ref 9 introduces a novel concept representing one of the most promising advances in oncological liver surgery so far Contrary to many surgical innovations, this one was somehow developed by chance In 2007, Dr Hans Schlitt from Regensburg, Germany, was planning an extended right hepatectomy in a patient with perihilar cholangiocarcinoma, but he realized intraoperatively that the future cholestatic liver remnant was too small to sustain the patient postoperatively He took a good, but uncommon surgical decision, by performing only a selective hepatico-jejunostomy on the left biliary system For the optimal positioning of the hepatico-jejunostomy, he had to divide the liver parenchyma along the falciform ligament, thereby completely devascularizing segment IV, that is, an in-situ split as performed for pediatric liver transplantation Finally, he ligated the right portal vein to induce hypertrophy of segments II to III Out of curiosity, he performed a CT scan on postoperative day 8 and, to his surprise, found that the left liver had grown enormously He decided to proceed with the removal of the diseased liver The patient, who had been at risk of liver failure a week prior, tolerated the removal just fine After this successful case, Dr Schlitt deliberately applied this approach in a patient with extensive colorectal liver metastases and in another patient with a large cholangiocarcinoma The enthusiasm for this approach was then shared with other surgeons, mostly from Germany, who used

Playing Play-Doh to prevent postoperative liver failure: the "ALPPS" approach.

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61086-2.pdf

Clavien P-A.

Papers

Challenges in evaluating surgical innovation.