Standardization of surgical technique in antireflux surgery: the LOTUS Trial experience.
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.
Attwood
Stephen E A
SE
Department of Surgery, Northumbria Healthcare, North Tyneside Hospital, Rake Lane, North Shields, NE29 8NH, United Kingdom. stephenattwood@onetel.com
Lundell
Lars
L
Ell
Christian
C
Galmiche
Jean-Paul
JP
Hatlebakk
Jan
J
Fiocca
Roberto
R
Lind
Tore
T
Eklund
Stefan
S
Junghard
Ola
O
D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D005260:Female; D018662:Fundoplication / Q000379:methods / Q000592:standards*; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D009853:Omeprazole