Bariatric Surgery Clinical Trial
Official title:
Defining Benchmarks in Bariatric Surgery - A Global Analysis of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy
Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery.
Design: Multicenter retrospective cohort study.
Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical
complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at
latest follow-up. Evolution of body mass index (BMI) will be also analyzed.
Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least
three continents, maintaining a prospective database, as well as having published previously
critically on their outcome.
Study population: Adult patients who underwent primary minimally invasive (laparoscopic /
robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May
2017.
Patient Exclusion criteria: detailed later.
Data collection Deadline: 1st September 2017 - 30 April 2018
Background With the growing complexity and cost of modern surgical practice, quality
assessment becomes mandatory. The notion of quality and quality assessment is widely
recognized and used in the world of business and manufacturing. A possible tool of quality
assessment is benchmarking. Benchmarking is a process of measuring performance by comparison
to the outcomes achieved by the best "service provider" in a specific domain. Usually, a
benchmark describes the ''best possible'' outcome of a benchmarking subject to whom
comparison can be performed. In the surgical community, however, such benchmarks - best
possible outcomes - for specific procedures, not just the pooled overall performance, are
lacking.
In 2016, a first landmark study defining benchmark outcomes for liver resection was published
in Annals of Surgery by a group of international authors invited and guided by our
department. More recently, further surgical outcomes (liver transplantation, minimally
invasive esophagectomy) have been benchmarked and have been accepted for publication.
Since laparoscopic bariatric surgery has become a standardized and widely performed procedure
worldwide, quality assessment is of major importance. To identify the best possible outcomes
(i.e. the benchmarks), data from high-volume centers (based on official IFSO criteria) in low
risk patients will be analyzed. These benchmarks will serve as "optimal outcomes" for
comparison with single center outcomes, high-risk patients and future developments.
Aim The primary aim is to define benchmark outcomes based on assessment of post procedural
complications according to the Clavien-Dindo classification for surgical complications and
the comprehensive complication index CCI™ at discharge and at 90-days. The CCI® expresses
morbidity on a continuous numeric scale from 0 (no complications) to 100 (death) by weighing
all postoperative complications according to the Clavien-Dindo classification for their
respective severity. Secondary outcome measure are patient survival and excess BMI loss
(EBMIL).
Data Security This multicenter international study is designed to harvest prospectively
collected retrospective data via an encrypted (i.e. Secure Sockets Layer (SSL) protocol)
online platform (https://bbenchmarks.org/) that meets Food and Drug Administration (FDA)
standards and is accessible only by secured login membership.
Confidential center specific data: Centers' outcomes will be individually analyzed in a first
step to screen for center-specific differences. Benchmarks will be computed from each
center's results in a second step. No center-specific data will be published. Instead, all
complications or adverse outcomes will be anonymously reported, as fractions of the total
study population. Each center, of course, will be free to publish their own data, as they
wish.
Further use of cohort data: Future studies based on the collected data may emerge from this
multicenter study, such as comparing outcomes in patients with or without specific
comorbidities with benchmark outcomes. For further data usage, additional ethics approval may
be required.
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