Repair of paraesophageal hiatal Hernias-is a fundoplication needed?: a randomized controlled pilot trial
Background - The need for a fundoplication during repair of paraesophageal hiatal hernias (PEH) remains unclear. Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects. The aim of this trial was to compare laparoscopic mesh-augmented hiat...
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| Main Authors: | , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
14 March 2015
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| In: |
Journal of the American College of Surgeons
Year: 2015, Volume: 221, Issue: 2, Pages: 602-610 |
| ISSN: | 1879-1190 |
| DOI: | 10.1016/j.jamcollsurg.2015.03.003 |
| Online Access: | Verlag, Volltext: https://doi.org/10.1016/j.jamcollsurg.2015.03.003 Verlag, Volltext: http://www.sciencedirect.com/science/article/pii/S107275151500191X 
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| Author Notes: | Beat P. Müller-Stich, Verena Achtstätter, Markus K. Diener, Matthias Gondan, René Warschkow, Francesco Marra, Andreas Zerz, Carsten N. Gutt, Markus W. Büchler, Georg R. Linke |
| Summary: | Background - The need for a fundoplication during repair of paraesophageal hiatal hernias (PEH) remains unclear. Prevention of gastroesophageal reflux represents a trade-off against the risk of fundoplication-related side effects. The aim of this trial was to compare laparoscopic mesh-augmented hiatoplasty with simple cardiophrenicopexy (LMAH-C) with laparoscopic mesh-augmented hiatoplasty with fundoplication (LMAH-F) in patients with PEH. - Study Design - The study was designed as a patient- and assessor-blinded randomized controlled pilot trial, registration number: DRKS00004492 (www.germanctr.de/). Patients with symptomatic PEH were eligible and assigned by central randomization to LMAH-C or LMAH-F. Endpoints were postoperative gastroesophageal reflux, complications, and quality of life 12 months postoperatively. - Results - Forty patients (9 male, 31 female) were randomized. Patients were well matched for baseline characteristics. At 3 months, the DeMeester score was higher after LMAH-C compared with LMAH-F (40.9 ± 39.9 vs. 9.6 ± 17; p = 0.048). At 12 months, the reflux syndrome score was higher after LMAH-C compared with LMAH-F (1.9 ± 1.2 vs. 1.1 ± 0.4; p = 0.020). In 53% of LMAH-C patients and 17% of LMAH-F patients, postoperative esophagitis was present (p = 0.026). Values of dysphagia (2.1 ± 1.6 vs 1.9 ± 1.4; p = 0.737), gas bloating (2.6 ± 1.4 vs 2.8 ± 1.4; p = 0.782), and quality of life (116.0 ± 16.2 vs 115.9 ± 15.8; p = 0.992) were similar. Relevant postoperative complications occurred in 4 (10%) patients and did not differ between the groups. - Conclusions - Laparoscopic repair of PEH should be combined with a fundoplication to avoid postoperative gastroesophageal reflux and resulting esophagitis. Fundoplication-related side effects do not appear to be clinically relevant. Multicenter randomized trials are required to confirm these findings. |
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| Item Description: | Gesehen am 03.08.2020 |
| Physical Description: | Online Resource |
| ISSN: | 1879-1190 |
| DOI: | 10.1016/j.jamcollsurg.2015.03.003 |