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 Citationer (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.

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Surgeons
Vol/bind	221
Udgave nummer	2
Sider (fra-til)	602-610
Antal sider	9
ISSN	1072-7515
DOI	https://doi.org/10.1016/j.jamcollsurg.2015.03.003
Status	Udgivet - 1 aug. 2015

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10.1016/j.jamcollsurg.2015.03.003

Citationsformater

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

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

language = "English",

volume = "221",

pages = "602--610",

journal = "Journal of the American College of Surgeons",

issn = "1072-7515",

publisher = "Elsevier",

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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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