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Randomized clinical trial of 270° posterior versus 180° anterior partial laparoscopic fundoplication for gastro-oesophageal reflux disease
被引:22
|作者:
Roks, D. J.
[1
]
Koetje, J. H.
[2
]
Oor, J. E.
[1
]
Broeders, J. A.
[1
]
Nieuwenhuijs, V. B.
[2
]
Hazebroek, E. J.
[1
]
机构:
[1] St Antonius Hosp Nieuwegein, Dept Surg, Koekoekslaan 1, NL-3435 CM Nieuwegein, Netherlands
[2] Isala Clin, Dept Surg, Zwolle, Netherlands
关键词:
CONVENTIONAL NISSEN FUNDOPLICATION;
DOUBLE-BLIND TRIAL;
TOUPET FUNDOPLICATION;
META-ANALYSIS;
ANTIREFLUX SURGERY;
FOLLOW-UP;
METAANALYSIS;
VALIDATION;
JUNCTION;
SCORE;
D O I:
10.1002/bjs.10500
中图分类号:
R61 [外科手术学];
学科分类号:
摘要:
Background: Partial fundoplications provide similar reflux control with fewer post-fundoplication symptoms compared with Nissen fundoplication for gastro-oesophageal reflux disease (GORD). The best choice of procedure for partial fundoplication remains unclear. The aim of this study was to compare the outcome of two different types of partial fundoplication for GORD. Methods: A double-blind RCT was conducted between 2012 and 2015 in two hospitals specializing in antireflux surgery. Patients were randomized to undergo either a laparoscopic 270 degrees posterior fundoplication (Toupet) or a laparoscopic 180 degrees anterior fundoplication. The primary outcome was postoperative dysphagia at 12 months, measured by the Dakkak score. Subjective outcome was analysed at 1, 3, 6 and 12 months after surgery. Objective reflux control was assessed before and 6 months after surgery. Results: Ninety-four patients were randomized to laparoscopic Toupet or laparoscopic 180 degrees anterior fundoplication (47 in each group). At 12months, 85 patients (90 per cent) were available for follow-up. Objective scores were available for 76 (81 per cent). Postoperative Dakkak dysphagia score at 12 months was similar in the two groups (mean 5.9 for Toupet versus 6.4 for anterior fundoplication; P=0.773). Subjective outcome at 12months demonstrated no significant differences in control of reflux or post-fundoplication symptoms. Overall satisfaction and willingness to undergo surgery did not differ between the groups. Postoperative endoscopy and 24-h pH monitoring showed no significant differences in mean oesophageal acid exposure time or recurrent pathological oesophageal acid exposure. Conclusion: Both types of partial fundoplication provided similar control of GORD at 12months, with no difference in post-fundoplication symptoms. Registration number: NTR5702 (www.trialregister.nl).
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页码:843 / 851
页数:9
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