Journal article
Repair of Paraesophageal Hiatal Hernias—Is a Fundoplication Needed? A Randomized Controlled Pilot Trial.
- Müller-Stich BP Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany. Electronic address: beat.mueller@med.uni-heidelberg.de.
- Achtstätter V Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
- Diener MK Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
- Gondan M Department of Psychology, University of Copenhagen, Denmark.
- Warschkow R Department of Surgery, Kantonsspital St Gallen, Switzerland.
- Marra F Department of Surgery, Kantonsspital St Gallen, Switzerland.
- Zerz A Department of Surgery, Kantonsspital Baselland, Liestal, Switzerland.
- Gutt CN Department of Surgery, Klinikum Memmingen, Germany.
- Büchler MW Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
- Linke GR Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.
- 2015-04-15
Published in:
- Journal of the American College of Surgeons. - 2015
Adult
Aged
Double-Blind Method
Female
Follow-Up Studies
Fundoplication
Gastroesophageal Reflux
Hernia, Hiatal
Herniorrhaphy
Humans
Laparoscopy
Male
Middle Aged
Pilot Projects
Postoperative Complications
Quality of Life
Surgical Mesh
Treatment Outcome
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1016/j.jamcollsurg.2015.03.003
- PMID 25868406
- Persistent URL
- https://sonar.ch/global/documents/44728
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