Defining Benchmarks in Bariatric Surgery
Condition: Benchmark; Bariatric Surgery; Roux-en-y Gastric Bypass; Sleeve Gastrectomy; Complications
Study type: Observational

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): bariatric surgery (RYGB or SG)
Intervention type(s): Procedure
Intervention description(s): laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy for severe obesity
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with severe obesity with a lower risk profile who undergo bariatric surgery