Abstract

Aim: To define benchmark outcomes in minimally-invasive esophagectomy                      

Design: Multicenter retrospective cohort study

Primary outcome measure: Morbidity as defined by the Clavien-Dindo classification for surgical complications and the comprehensive complication index at discharge and after 3 months

Hospital eligibility: High volume centers (> 20 esophagectomies / year), conducting a prospective database as well as previous publications critically reporting on their outcome

Study population: Adult patients who underwent totally minimally-invasive (laparoscopic / thoracoscopic) Ivor Lewis or McKeown esophagectomy from 01.06.2011 to 31.05.2016.

Exclusion criteria:

• Open procedures
• Hhybrid procedures

Data collection Deadline: to be announced

Introduction

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 in order to enable for outcome comparison and improvement within a specific domain. In the surgical community, however, such standard outcome measures and multicenter comparison of results are not available and benchmarking for the best possible results for specific procedures is lacking.

Recently, a first landmark study defining benchmark outcomes for liver resection has been presented at the 2016 ASA meeting in Chicago (1).

Since esophagectomy is a high-risk procedure with a significant morbidity and an accepted perioperative mortality rate of about 5%, quality assessment is of major importance. Up to date no data is available on best achievable results in major esophageal procedures. To identify the best possible outcome (i.e. benchmarking), data from high-volume centers in low risk patients will be thoroughly analyzed. These benchmark outcomes will serve as “negative controls” for comparison with single center outcomes, high-risk patients and future developments.

Policy Securing

Confidential center specific data: 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.

Authorship: No data will be submitted or published without authorization from each participating center. Each center will be represented by two co-authors. In the ideal case, there will be one junior author who will coordinate data collection with Dr. Henner Schmidt (coordinator of the study from Zurich). If necessary, three authors may be included for one center in the authorship list.

Further use of cohort data: Future studies based on the collected data will hopefully emerge from this multicenter study e.g. comparing outcomes in patients undergoing open or hybrid esophagectomy techniques with the benchmark outcomes.

Methods

Objective:

To conduct a retrospective multicenter cohort study to define benchmark criteria for best achievable outcomes in minimally-invasive esophagectomy to serve as controls in quality assessment. The benchmark criteria will be derived from postoperative mortality and morbidity as well as patient survival.

Aims:

The primary aim is to define benchmark outcomes by identifying post procedural complications according to the Clavien-Dindo classification for surgical complications (2,3) and the comprehensive complication index CCI (4) at discharge and after 3 months.

Secondary aim:

• Patient survival

Time period:

• The study will cover a 5-year period, from 01.06.2011 to 31.05.2016.

Hospital inclusion criteria

• Single centers performing > 20 esophagectomies per year (minimally-invasive and other procedures)
• Centers having a prospective database from which most of the data can be extracted

Patient eligibility

Inclusion criteria

• Patients who underwent totally minimally-invasive (laparoscopic / thoracoscopic) transthoracic Ivor Lewis or McKeown esophagectomies.

Exclusion criteria

• Open and hybrid procedures

Outcome Measures

Primary outcome measure

The primary outcome measure is identifying post procedural complications according to the Clavien-Dindo classification for surgical complications (2,3) and the comprehensive complication index (CCI) (4) at discharge and three months. In order to focus on the most frequent complications, investigators should focus on the complications basic platform as published by the esophagectomy complications consensus group (ECCG) (5). This requires the patient to have a documented 3-months follow-up in the center conducting the study. Every complication has to be assessed according to the Clavien-Dindo classification. The corresponding CCI will be calculated by the coordinating center in Zurich.

Governance

Data will be collected via a secure online webpage, provided by the University Hospital of Zurich. This website uses a data entry management system (DEMS) to meet international standards for online databases including fully anonymized data. Data will not be published with hospital identifiers.

Collecting data

Local collaborators: Most hospitals will have two local investigators. A senior and a junior investigator. The junior collaborator will be in regular contact with the study coordinator in Zurich. The junior investigator will be responsible for:

• Gaining local research ethics approval
• Identifying and including all eligible patients
• Accurately collect baseline and follow-up data
• Submit data to the online DEMS database

References

1. Rössler F, Sapisochin G, Song G, et al. Defining Benchmarks for major liver surgery. A multicenter analysis of 5202 living liver donors. Ann Surg in press.
2. Dindo D, Demartines N, Clavien PA. Classification of Surgical Complications. A New Proposal with Evaluation in a Cohort of 6336 Patients and Results of a Survey. Ann Surg. 2004;240:205-213.
3. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187-196.
4. Slankamenac K, Graf R, Barkun J, et al. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013;258:1-7.
5. Low DE, Alderson D, Cecconello I, et al. International consensus on standardization of data collection for complications associated with esophagectomy. Ann Surg. 2015;262:286-294

The esoBenchmark.org Team