Repair of paraesophageal hiatal hernias – Is a fundoplication needed?: A randomized controlled pilot trial

Beat P. Müller-Stich; Verena Achtstätter; Markus K. Diener; Matthias Gondan; René Warschkow; Francesco Marra; Andreas Zerz; Carsten N. Gutt; Markus W. Büchler; Georg L. Linke

doi:10.1016/j.jamcollsurg.2015.03.003

Repair of paraesophageal hiatal hernias – Is a fundoplication needed? A randomized controlled pilot trial

Beat P. Müller-Stich, Verena Achtstätter, Markus K. Diener, Matthias Gondan, René Warschkow, Francesco Marra, Andreas Zerz, Carsten N. Gutt, Markus W. Büchler, Georg L. Linke

26 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Journal of the American College of Surgeons
Volume	221
Issue number	2
Pages (from-to)	602-610
Number of pages	9
ISSN	1072-7515
DOIs	https://doi.org/10.1016/j.jamcollsurg.2015.03.003
Publication status	Published - 1 Aug 2015

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Müller-Stich, B. P., Achtstätter, V., Diener, M. K., Gondan, M., Warschkow, R., Marra, F., Zerz, A., N. Gutt, C., Büchler, M. W., & Linke, G. L. (2015). Repair of paraesophageal hiatal hernias – Is a fundoplication needed? A randomized controlled pilot trial. Journal of the American College of Surgeons, 221(2), 602-610. https://doi.org/10.1016/j.jamcollsurg.2015.03.003

Müller-Stich, BP, Achtstätter, V, Diener, MK, Gondan, M, Warschkow, R, Marra, F, Zerz, A, N. Gutt, C, Büchler, MW & Linke, GL 2015, 'Repair of paraesophageal hiatal hernias – Is a fundoplication needed? A randomized controlled pilot trial', Journal of the American College of Surgeons, vol. 221, no. 2, pp. 602-610. https://doi.org/10.1016/j.jamcollsurg.2015.03.003

@article{288bf3e78dae479ebcde632b2f014f47,

title = "Repair of paraesophageal hiatal hernias – Is a fundoplication needed?: A randomized controlled pilot trial",

abstract = "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.",

author = "M{\"u}ller-Stich, {Beat P.} and Verena Achtst{\"a}tter and Diener, {Markus K.} and Matthias Gondan and Ren{\'e} Warschkow and Francesco Marra and Andreas Zerz and {N. Gutt}, Carsten and B{\"u}chler, {Markus W.} and Linke, {Georg L.}",

year = "2015",

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day = "1",

doi = "10.1016/j.jamcollsurg.2015.03.003",

language = "English",

volume = "221",

pages = "602--610",

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issn = "1072-7515",

publisher = "Elsevier",

number = "2",

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TY - JOUR

T1 - Repair of paraesophageal hiatal hernias – Is a fundoplication needed?

T2 - A randomized controlled pilot trial

AU - Müller-Stich, Beat P.

AU - Achtstätter, Verena

AU - Diener, Markus K.

AU - Gondan, Matthias

AU - Warschkow, René

AU - Marra, Francesco

AU - Zerz, Andreas

AU - N. Gutt, Carsten

AU - Büchler, Markus W.

AU - Linke, Georg L.

PY - 2015/8/1

Y1 - 2015/8/1

N2 - 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.

AB - 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.

U2 - 10.1016/j.jamcollsurg.2015.03.003

DO - 10.1016/j.jamcollsurg.2015.03.003

M3 - Journal article

C2 - 25868406

SN - 1072-7515

VL - 221

SP - 602

EP - 610

JO - Journal of the American College of Surgeons

JF - Journal of the American College of Surgeons

IS - 2

ER -

Repair of paraesophageal hiatal hernias – Is a fundoplication needed? A randomized controlled pilot trial

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