Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial. The Netherlands Antireflux Surgery Study Group.

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Title: Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial. The Netherlands Antireflux Surgery Study Group.
Authors: Bais JE (AUTHOR), Bartelsman JFW (AUTHOR), Bonjer HJ (AUTHOR), Cuesta MA (AUTHOR), Go PMN (AUTHOR), Klinkenberg-Knol EC (AUTHOR), van Lanschot JJB (AUTHOR), Nadorp JHS (AUTHOR), Smout AJP (AUTHOR), van der Graaf Y (AUTHOR), Gooszen HG (AUTHOR), Bais, J E (AUTHOR), Bartelsman, J F (AUTHOR), Bonjer, H J (AUTHOR), Cuesta, M A (AUTHOR), Go, P M (AUTHOR), Klinkenberg-Knol, E C (AUTHOR), van Lanschot, J J (AUTHOR), Nadorp, J H (AUTHOR), Smout, A J (AUTHOR)
Source: Lancet. 1/15/2000, Vol. 355 Issue 9199, p170-174. 5p.
Abstract: Background: For the surgical treatment of gastrooesophageal reflux disease (GORD), laparoscopic Nissen fundoplication has largely replaced the open procedure. Retrospective and prospective non-randomised studies have shown similar results after laparoscopic Nissen fundoplication compared with the open procedure.Methods: In a multicentre randomised trial candidates for surgical treatment of GORD were randomly assigned to either laparoscopic or open 360 degrees Nissen fundoplication. Primary endpoints were dysphagia, recurrent GORD, and intrathoracic hernia. Secondary endpoints were effectiveness and quality of life. This planned interim analysis focuses on endpoints and complications and in-hospital costs.Findings: At the time of interim analysis, 11 patients in the laparoscopic group and one in the conventional group had reached a primary endpoint (p=0.01; relative risk=8.8, 95% CI 1.2-66.3). This difference was caused mainly by whether or not patients had dysphagia (seven patients in the laparoscopic group and none in the conventional group, p=0.016).Interpretation: Although laparoscopic Nissen fundoplication was as effective as the open procedure in controlling reflux, the significantly higher risk of reaching a primary endpoint in the laparoscopic group led us to stop the study. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Laparoscopic or conventional Nissen fundoplication for gastro-oesophageal reflux disease: randomised clinical trial. The Netherlands Antireflux Surgery Study Group.
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  Data: <searchLink fieldCode="AR" term="%22Bais+JE%22">Bais JE</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bartelsman+JFW%22">Bartelsman JFW</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bonjer+HJ%22">Bonjer HJ</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cuesta+MA%22">Cuesta MA</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Go+PMN%22">Go PMN</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Klinkenberg-Knol+EC%22">Klinkenberg-Knol EC</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22van+Lanschot+JJB%22">van Lanschot JJB</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nadorp+JHS%22">Nadorp JHS</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Smout+AJP%22">Smout AJP</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22van+der+Graaf+Y%22">van der Graaf Y</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gooszen+HG%22">Gooszen HG</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bais%2C+J+E%22">Bais, J E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bartelsman%2C+J+F%22">Bartelsman, J F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bonjer%2C+H+J%22">Bonjer, H J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cuesta%2C+M+A%22">Cuesta, M A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Go%2C+P+M%22">Go, P M</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Klinkenberg-Knol%2C+E+C%22">Klinkenberg-Knol, E C</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22van+Lanschot%2C+J+J%22">van Lanschot, J J</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nadorp%2C+J+H%22">Nadorp, J H</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Smout%2C+A+J%22">Smout, A J</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 1/15/2000, Vol. 355 Issue 9199, p170-174. 5p.
– Name: Abstract
  Label: Abstract
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  Data: <bold>Background: </bold>For the surgical treatment of gastrooesophageal reflux disease (GORD), laparoscopic Nissen fundoplication has largely replaced the open procedure. Retrospective and prospective non-randomised studies have shown similar results after laparoscopic Nissen fundoplication compared with the open procedure.<bold>Methods: </bold>In a multicentre randomised trial candidates for surgical treatment of GORD were randomly assigned to either laparoscopic or open 360 degrees Nissen fundoplication. Primary endpoints were dysphagia, recurrent GORD, and intrathoracic hernia. Secondary endpoints were effectiveness and quality of life. This planned interim analysis focuses on endpoints and complications and in-hospital costs.<bold>Findings: </bold>At the time of interim analysis, 11 patients in the laparoscopic group and one in the conventional group had reached a primary endpoint (p=0.01; relative risk=8.8, 95% CI 1.2-66.3). This difference was caused mainly by whether or not patients had dysphagia (seven patients in the laparoscopic group and none in the conventional group, p=0.016).<bold>Interpretation: </bold>Although laparoscopic Nissen fundoplication was as effective as the open procedure in controlling reflux, the significantly higher risk of reaching a primary endpoint in the laparoscopic group led us to stop the study. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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