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Clinical Trial
. 2000 Jan 15;355(9199):170-4.
doi: 10.1016/s0140-6736(99)03097-4.

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

J E Bais  1 , J F Bartelsman, H J Bonjer, M A Cuesta, P M Go, E C Klinkenberg-Knol, J J van Lanschot, J H Nadorp, A J Smout, Y van der Graaf, H G Gooszen
Affiliations
Clinical Trial

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

J E Bais et al. Lancet. .

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.

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Comment in

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    Bloechle C, Mann O, Gawad KA, Izbicki JR. Bloechle C, et al. Lancet. 2000 Jul 1;356(9223):69; author reply 72-3. doi: 10.1016/S0140-6736(05)73399-7. Lancet. 2000. PMID: 10892781 No abstract available.
  • Gastro-oesophageal reflux disease.
    de Brauw LM, Beets GL. de Brauw LM, et al. Lancet. 2000 Jul 1;356(9223):69-70; author reply 72-3. doi: 10.1016/S0140-6736(05)73400-0. Lancet. 2000. PMID: 10892782 No abstract available.
  • Gastro-oesophageal reflux disease.
    Gorecki PJ, Hinder RA. Gorecki PJ, et al. Lancet. 2000 Jul 1;356(9223):70; author reply 72-3. doi: 10.1016/S0140-6736(05)73401-2. Lancet. 2000. PMID: 10892783 No abstract available.
  • Gastro-oesophageal reflux disease.
    Booth M, Dehn TC. Booth M, et al. Lancet. 2000 Jul 1;356(9223):70-1; author reply 72-3. doi: 10.1016/s0140-6736(05)73402-4. Lancet. 2000. PMID: 10892784 No abstract available.
  • Gastro-oesophageal reflux disease.
    Pellegrini CA. Pellegrini CA. Lancet. 2000 Jul 1;356(9223):71; author reply 72-3. doi: 10.1016/S0140-6736(05)73403-6. Lancet. 2000. PMID: 10892785 No abstract available.
  • Gastro-oesophageal reflux disease.
    de Beaux AC, Watson DI, Jamieson GG. de Beaux AC, et al. Lancet. 2000 Jul 1;356(9223):71-2; author reply 72-3. doi: 10.1016/S0140-6736(05)73404-8. Lancet. 2000. PMID: 10892786 No abstract available.

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