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Is partial or total fundoplication superior in laparoscopic antireflux surgery?
In this randomized clinical trial including 456 patients, partial and total fundoplication were equally effective in reducing esophageal acid exposure after 3 years, while mechanical adverse effects were more common after total fundoplication.
Although partial and total fundoplication could be recommended for treatment of gastroesophageal reflux, partial fundoplication might be superior by inducing less dysphagia.
Restoration of the esophagogastric junction competence is critical for effective long-term treatment of gastroesophageal reflux disease. Surgical repair results in such restoration, but mechanical adverse effects seem unavoidable. Minimizing these adverse effects without jeopardizing reflux control is warranted.
To determine whether partial fundoplication (PF) or total fundoplication (TF) is superior in laparoscopic antireflux surgery.
Design, Setting, and Participants
In this double-blind, randomized clinical trial of 1171 patients scheduled for laparoscopic antireflux surgery at a single university-affiliated center between November 19, 2001, and January 24, 2006, 456 patients were randomized and followed up for 5 years. Data were collected from November 2001 to April 2012, and data were analyzed from April 2012 to September 2018.
A 270° posterior PF or a 360° Nissen TF.
Main Outcomes and Measures
Esophageal acid exposure at 3 years after surgery.
Of the 456 randomized patients, 268 (58.8%) were male, and the mean (SD) age was 49.0 (11.7) years. A total of 229 patients were randomized to PF, and 227 patients were randomized to TF. At 3 years postoperatively, the median (interquartile range) esophageal acid exposure was reduced from 14.6% (9.8-21.9) to 1.8% (0.7-4.4) after PF and from 16.0% (10.4-22.7) to 2.5% (0.8-6.8) after TF (P = .31). Likewise, reflux symptoms were equally and effectively controlled. Early postoperative dysphagia (6 weeks) was common in both groups but then decreased toward normality. A small but statistically significant difference in favor of PF was noted in the mean (SD) scoring of dysphagia for liquids at 6 weeks (PF, 1.6 [0.9]; TF, 1.9 [1.3]; P = .01) and for solid food at 12 months (PF, 1.3 [1.0]; TF, 1.9 [1.4]; P < .001) and 24 months (PF, 1.3 [0.9]; TF, 1.7 [1.2]; P = .001). Quality of life was reduced before surgery but increased to normal values after surgery and remained so over 5-year follow-up, with no difference between the groups.
Conclusions and Relevance
The results from this randomized clinical trial suggest that although PF and TF could be recommended for treatment of gastroesophageal reflux disease, PF might be superior by inducing less dysphagia.
ClinicalTrials.gov identifier: NCT03659487
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: December 6, 2018.
Corresponding Author: Bengt S. Håkanson, MD, PhD, Department of Surgery, Ersta Hospital, PO Box 4619, SE 116 91 Stockholm, Sweden (email@example.com).
Published Online: March 6, 2019. doi:10.1001/jamasurg.2019.0047
Author Contributions: Dr Håkanson had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Håkanson, Thorell.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Håkanson, Bylund.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Håkanson, Bylund, Thorell.
Obtained funding: Håkanson, Thorell.
Administrative, technical, or material support: Håkanson, Bylund, Thorell.
Study supervision: Håkanson, Lundell, Thorell.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was financially supported by grants 2003-7558 and 2004-7620 from the Stockholm City Council and grant 140604 from the Erling-Persson Family Foundation.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 4.
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