Diseases of the Esophagus (2020) 33, 1–15 DOI: 10.1093/dote/doz007 Original Article Study protocol for a multicenter prospective cohort study on esophagogastric anastomoses and anastomotic leak (the Oesophago-Gastric Anastomosis Audit/OGAA) R. P. T. Evans, 1 P. Singh, 1 , 2 D. Nepogodiev, 1 , 3 J. Bundred, 1 S. Kamarajah, 1 B. Jefferies, 1 K. Siaw-Acheampong, 1 K. Wanigasooriya, 1 S. McKay, 1 I. Mohamed, 1 T. Whitehouse, 4 D. Alderson, 5 J. Gossage, 6 R. van Hillegersberg, 7 R. S. Vohra, 8 E. A. Griffths 3, 9 1 West Midlands Research Collaborative, and 3 Academic Department of Surgery, and 4 Department of Anaesthesia, and 9 Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, and 2 Department of Upper GI Surgery, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foun- dation Trust, Birmingham, and 5 The Royal College of Surgeons England, and 6 Department of Upper GI Surgery, St Thomas’ Hospital, Guys and St. Thomas’ Foundation Trust, London, and 8 Queen’s Medical Centre Nottingham University Hospitals, Nottingham, UK; and 7 University Medical Center Utrecht, Utrecht, Netherlands SUMMARY. Esophagectomy is a mainstay in curative treatment for esophageal cancer; however, the reported techniques and outcomes can vary greatly. Thirty-day mortality of patients with an intact anastomosis is 2–3% as compared to 17–35% in patients who have an anastomotic leak. The subsequent management of leaks poste- sophagectomy has great global variability with little consensus on a gold standard of practice. The aim of this multi- centre prospective audit is to analyze current techniques of esophagogastric anastomosis to determine the effect on the anastomotic leak rate. Leak rates and leak management will be assessed to determine their impact on patient outcomes. A 12-month international multicentre prospective audit started in April 2018 and is coordinated by a team from the West Midlands Research Collaborative. This will include patients undergoing esophagectomy over 9 months and encompassing a 90-day follow-up period. A pilot data collection period occurred at four UK centers in 2017 to trial the data collection form. The audit standards will include anastomotic leak and the conduit necrosis rate should be less than 13% and major postoperative morbidity (Clavien–Dindo Grade III or more) should be less than 35%. The 30-day mortality rate should be less than 5% and the 90-day mortality rate should be less than 8%. This will be a trainee-led international audit of esophagectomy practice. Key support will be given by consultant colleagues and anesthetists. Individualized unit data will be distributed to the respective contributing sites. An overall anonymized report will be made available to contributing units. Results of the audit will be published in peer-reviewed journals with all collaborators fully acknowledged. The key information and results from the audit will be disseminated at relevant scientifc meetings. KEY WORDS: anastomotic leak, esophagectomy, outcome assessment (health care), prospective study. Address correspondence to: Mr E. A. Griffths, Consultant Upper GI Surgeon, University Hospitals Birmingham NHS Foundation Trust, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK. Email: ewen.griffths@uhb.nhs.uk On behalf of the West Midlands Research Collaborative Guarantor of the article: Ewen Griffths Specifc author contributions: Conception, design, writing, and editing of the protocol: Richard Evans, Pritam Singh, Ewen Griffths; Design and writing of the protocol: Derek Alderson, Ravinder Vohra, James Gossage, Tony Whitehouse, Richard van Hillegersberg, Dmitri Nepogodiev, James Bundred, Sivesh Kamarajah, Siobhan McKay, Imran Mohamed, Benjamin Jefferies, Kasun Wanigasooriya, Kwabena Siaw-Acheampong; All authors read and approved the fnal manuscript. Financial support: This research received no specifc grant from any funding agency in the public, commercial, or not-for-proft sectors. The patient support group Oesophageal Patients Association (Queen Elizabeth Hospital Branch) kindly paid for the website hosting (www.ogaa.org.uk). Potential competing interests: None. C The Author(s) 2019. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 1 Downloaded from https://academic.oup.com/dote/article/33/1/doz007/5393317 by guest on 07 November 2022