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.
RCT Entities:
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: P J Devereaux; Mohit Bhandari; Mike Clarke; Victor M Montori; Deborah J Cook; Salim Yusuf; David L Sackett; Claudio S Cinà; S D Walter; Brian Haynes; Holger J Schünemann; Geoffrey R Norman; Gordon H Guyatt Journal: BMJ Date: 2005-01-08
Authors: Dimitrios Stefanidis; William W Hope; Geoffrey P Kohn; Patrick R Reardon; William S Richardson; Robert D Fanelli Journal: Surg Endosc Date: 2010-08-20 Impact factor: 4.584
Authors: Johannes Miholic; Joumanah Hafez; Johannes Lenglinger; Fritz Wrba; Christiane Wischin; Katrin Schütz; Marcus Hudec Journal: Surg Endosc Date: 2012-05-31 Impact factor: 4.584
Authors: Oliver C Bellevue; Brian E Louie; Zeljka Jutric; Alexander S Farivar; Ralph W Aye Journal: J Gastrointest Surg Date: 2017-10-02 Impact factor: 3.452
Authors: S E Attwood; L Lundell; J G Hatlebakk; S Eklund; O Junghard; J-P Galmiche; C Ell; R Fiocca; T Lind Journal: J Gastrointest Surg Date: 2008-08-16 Impact factor: 3.452