4.5 Article

Proposal for Standardized Tabular Reporting of Observational Surgical Studies Illustrated in a Study on Primary Repair of Bile Duct Injuries

Journal

JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Volume 221, Issue 3, Pages 678-688

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LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1016/j.jamcollsurg.2015.06.004

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BACKGROUND: A standard format for reporting observational surgical studies does not exist. This creates difficulties in comparing studies and in performing synthesis through systematic reviews and meta-analyses. This article proposes a method called standard tabular reporting and illustrates its use in a case series of bile duct reconstructions for biliary injuries occurring during cholecystectomy. STUDY DESIGN: A database dealing with biliary injuries was constructed in sections. Each section was designed to be turned into a table covering one element of the subject. Whenever possible, American College of Surgeons NSQIP Classic Variables and Definitions were used for forming sections and tables. However, most tables are original and specific to biliary injury. The database was populated from clinical records of patients who sustained a biliary injury during cholecystectomy. RESULTS: Tables were created dealing with the following subjects: demographics, index operation, presentation, classification of injury, preoperative risk assessment, preoperative laboratory values, operative repair technique, postoperative complications, and long-term outcomes. Between 1997 and 2013, 122 primary bile duct reconstructions were performed, with 1 mortality and 47 complications. Good long-term results were obtained in 113 (92.6%) patients. No secondary surgical reconstructions have been needed. CONCLUSIONS: Presentation of data in a standard format would facilitate comparison and synthesis of observational studies on the same subject. The biliary reconstructive methods used resulted in very satisfactory outcomes. (C) 2015 by the American College of Surgeons

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