title: Laparoscopic Mesh-augmented Hiatoplasty With Cardiophrenicopexy Versus Laparoscopic Nissen Fundoplication for the Treatment of Gastroesophageal Reflux Disease: A Double-center Randomized Controlled Trial.
abstract: OBJECTIVE
  Laparoscopic mesh-augmented hiatoplasty with cardiophrenicopexy (LMAH-C) might represent an alternative treatment of gastroesophageal reflux disease (GERD) and may provide durable reflux control without fundoplication. The expected benefit is the prevention of fundoplication-related side effects. Aim of the present trial was to compare LMAH-C with laparoscopic Nissen fundoplication (LNF) in patients with GERD.
  
  
  METHODS
  In a double-center randomized controlled trial (RCT) patients with proven GERD were eligible and assigned by central randomization to either LMAH-C (n = 46) or LNF (n = 44). The indigestion subscore of the Gastrointestinal Symptom Rating Scale questionnaire (GSRS) indicating gas-related symptoms as possible side effects of LNF was the primary endpoint. Secondary endpoints comprised pH testing and endoscopy and other symptoms measured by the GSRS, dysphagia, and the Gastrointestinal Quality of Life Index. The follow-up period was 36 months.
  
  
  RESULTS
  Indigestion subscore (LMAH-C 2.9 ± 1.5 vs LNF 3.7 ± 1.6; P = 0.031) but not dysphagia (2.8 ± 1.9 vs 2.3 ± 1.7; P = 0.302) and quality of life (106.9 ± 25.5 vs 105.8 ± 24.9; P = 0.838) differed between the groups at 36 months postoperatively. Although the reflux subscore improved in both groups, it was worse in LMAH-C patients (2.5 ± 1.6 vs 1.6 ± 1.0; P = 0.004) corresponding to a treatment failure of 77.3% in LMAH-C patients and of 34.1% in LNF patients (P < 0.001).
  
  
  CONCLUSIONS
  LNF is more effective in the treatment of GERD than LMAH-C. Procedure-related side effects seem to exist but do not affect the quality of life. Laparoscopic fundoplication therefore remains the standard surgical treatment for GERD.
authors.affiliation: *Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany †Study Centre of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany ‡Department of Surgery, Kantonsspital St. Gallen, St. Gallen, Switzerland §Division of Gastroenterology, Department of Internal Medicine, Kantonsspital St. Gallen, St. Gallen, Switzerland ||Department of Surgery, Kantonsspital Baselland, Liestal, Switzerland ¶Department of Surgery, Klinikum Memmingen, Memmingen, Germany.
authors.forename: Beat P
authors.initials: BP
authors.lastname: Müller-Stich
authors.forename: Georg R
authors.initials: GR
authors.lastname: Linke
authors.forename: Jonas
authors.initials: J
authors.lastname: Senft
authors.forename: Verena
authors.initials: V
authors.lastname: Achtstätter
authors.forename: Philip C
authors.initials: PC
authors.lastname: Müller
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
authors.forename: Rene
authors.initials: R
authors.lastname: Warschkow
authors.forename: Francesco
authors.initials: F
authors.lastname: Marra
authors.forename: Bruno M
authors.initials: BM
authors.lastname: Schmied
authors.forename: Jan
authors.initials: J
authors.lastname: Borovicka
authors.forename: Lars
authors.initials: L
authors.lastname: Fischer
authors.forename: Andreas
authors.initials: A
authors.lastname: Zerz
authors.forename: Carsten N
authors.initials: CN
authors.lastname: Gutt
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
mesh_terms: D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016037:Single-Blind Method; D013526:Surgical Mesh; D016896:Treatment Outcome