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.
  
  
  METHODS
  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.
authors: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany. Electronic address: beat.mueller@med.uni-heidelberg.de.
authors: Beat P
authors: BP
authors: Müller-Stich
authors: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
authors: Verena
authors: V
authors: Achtstätter
authors: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
authors: Markus K
authors: MK
authors: Diener
authors: Department of Psychology, University of Copenhagen, Denmark.
authors: Matthias
authors: M
authors: Gondan
authors: Department of Surgery, Kantonsspital St Gallen, Switzerland.
authors: René
authors: R
authors: Warschkow
authors: Department of Surgery, Kantonsspital St Gallen, Switzerland.
authors: Francesco
authors: F
authors: Marra
authors: Department of Surgery, Kantonsspital Baselland, Liestal, Switzerland.
authors: Andreas
authors: A
authors: Zerz
authors: Department of Surgery, Klinikum Memmingen, Germany.
authors: Carsten N
authors: CN
authors: Gutt
authors: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
authors: Markus W
authors: MW
authors: Büchler
authors: Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
authors: Georg R
authors: GR
authors: Linke
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication; D005764:Gastroesophageal Reflux / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006551:Hernia, Hiatal / Q000601:surgery*; D059685:Herniorrhaphy / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011788:Quality of Life; D013526:Surgical Mesh; D016896:Treatment Outcome