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Preliminary Results of a Prospective Randomized Functional and Clinical Study

Frank Alexander Granderath, MD; Ursula Maria Schweiger, MD; Thomas Kamolz, PhD; Kai Uwe Asche, MD; Rudolph Pointner, MD

Arch Surg. 2005;140:40-48.

Background  Postoperative intrathoracic wrap migration is the most frequent morphological complication after laparoscopic antireflux surgery. Previous authors have studied the use of prosthetic materials for hiatal closure to prevent recurrence of hiatal hernia and/or postoperative intrathoracic wrap herniation.

Hypothesis  Patients with prosthetic hiatal closure have a higher rate of short-term dysphagia but a significantly lower rate of postoperative intrathoracic wrap herniation at follow-up.

Design  Prospective randomized trial. We compared patients who underwent laparoscopic Nissen fundoplication with simple sutured hiatoplasty with those who underwent laparoscopic Nissen fundoplication with prosthetic hiatal closure.

Setting  Universtity-affiliated community hospital.

Patients  One hundred consecutive patients undergoing laparoscopic Nissen fundoplication for gastroesophageal reflux disease and hiatal hernia repair.

Intervention  Laparoscopic Nissen fundoplication with simple sutured crural closure (n = 50 [group 1]) vs laparoscopic Nissen fundoplication with simple sutured cruroplasty and onlay of a polypropylene mesh (n = 50 [group 2]).

Main Outcome Measures  Recurrences; complications; results of esophageal manometry, 24-hour pH monitoring, esophagogastroduodenoscopy, and barium swallow test; and symptomatic outcome.

Results  Patients in both groups had similar preoperative values in esophageal manometry, 24-hour pH monitoring, and symptom scoring. At the 3-month and 1-year follow-ups, functional outcome variables (lower esophageal sphincter pressure and DeMeester score) improved significantly compared with the preoperative values. A higher postoperative dysphagia rate could be evaluated in group 2. An intrathoracic wrap migration occurred in 13 patients (26%) in group 1 vs 4 (8%) in group 2 (P<.001).

Conclusion  Laparoscopic Nissen fundoplication with prosthetic cruroplasty is an effective procedure to reduce the incidence of postoperative hiatal hernia recurrence and intrathoracic wrap herniation.

Author Affiliations: Department of General Surgery (Drs Granderath, Schweiger, Asche, and Pointner) and Division of Clinical Psychology, Department of General Surgery (Dr Kamolz), Hospital Zell am See, Zell am See, Austria.

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