Document Detail


Standardization of surgical technique in antireflux surgery: the LOTUS Trial experience.
MedLine Citation:
PMID:  18224465     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: To date, it has been difficult to compare medical therapy for gastroesophageal reflux disease with that of surgical management from a scientific viewpoint, mainly because of the lack of standardization of the operative technique. This study was designed to identify a methodology for standardization of surgical technique and to measure the effectiveness of this standardization. METHODS: Surgeons contributing to a major international multicenter trial comparing optimum medical therapy with surgical therapy for treatment of gastroesophageal reflux attempted to optimize their surgical techniques so that a realistic comparison could be made that may aid clinical decision-making. The surgeons met, shared their techniques using video, and produced a standardized set of criteria for the surgical centers and a common operative technique. Data collection methods ensured accuracy of the records of the procedure applied and the data were analyzed for consistency with set surgical standards. RESULTS: There was a high degree of conformity (>95%) between the recommended method of performing a Nissen fundoplication as defined in the trial protocol, and variations were restricted to isolated individuals. The operations were completed without mortality, few conversions, and with very low postoperative morbidity. CONCLUSIONS: This study has shown that, contrary to commonly held belief, surgeons are able to standardize their work for the purposes of measuring the outcome of an operative procedure within the context of a randomized, controlled trial.
Authors:
Stephen E A Attwood; Lars Lundell; Christian Ell; Jean-Paul Galmiche; Jan Hatlebakk; Roberto Fiocca; Tore Lind; Stefan Eklund; Ola Junghard;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  World journal of surgery     Volume:  32     ISSN:  0364-2313     ISO Abbreviation:  World J Surg     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-05-19     Completed Date:  2008-10-01     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7704052     Medline TA:  World J Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  995-8     Citation Subset:  IM    
Affiliation:
Department of Surgery, Northumbria Healthcare, North Tyneside Hospital, Rake Lane, North Shields, NE29 8NH, United Kingdom. stephenattwood@onetel.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Ulcer Agents / therapeutic use
Female
Fundoplication / methods,  standards*
Gastroesophageal Reflux / drug therapy,  surgery*
Humans
Laparoscopy
Male
Middle Aged
Omeprazole / therapeutic use
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Ulcer Agents; 73590-58-6/Omeprazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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