Biologic Prosthesis to Prevent Recurrence after Laparoscopic Paraesophageal Hernia Repair: Long-term Follow-up from a Multicenter, Prospective, Randomized Trial - 22/09/11
, Carlos A. Pellegrini, MD, FACS a, John G. Hunter, MD, FACS c, Michael L. Brunt, MD, FACS f, Nathaniel J. Soper, MD, FACS e, Brett C. Sheppard, MD, FACS c, Nayak L. Polissar, PhD b, Moni B. Neradilek, MS b, Lee M. Mitsumori, MD a, Charles A. Rohrmann, MD a, Lee L. Swanstrom, MD, FACS d
Correspondence address: Brant K Oelschlager, MD, Department of Surgery, University of Washington, 1959 NE Pacific St, Box 356410, Seattle, WA 98195-6410Résumé |
Background |
In 2006, we reported results of a randomized trial of laparoscopic paraesophageal hernia repair (LPEHR), comparing primary diaphragm repair (PR) with primary repair buttressed with a biologic prosthesis (small intestinal submucosa [SIS]). The primary endpoint, radiologic hiatal hernia (HH) recurrence, was higher with PR (24%) than with SIS buttressed repair (9%) after 6 months. The second phase of this trial was designed to determine the long-term durability of biologic mesh-buttressed repair.
Methods |
We systematically searched for the 108 patients in phase I of this study to assess current clinical symptoms, quality of life (QOL) and determine ongoing durability of the repair by obtaining a follow-up upper gastrointestinal series (UGI) read by 2 radiologists blinded to treatment received. HH recurrence was defined as the greatest measured vertical height of stomach being at least 2 cm above the diaphragm.
Results |
At median follow-up of 58 months (range 42 to 78 mo), 10 patients had died, 26 patients were not found, 72 completed clinical follow-up (PR, n = 39; SIS, n = 33), and 60 repeated a UGI (PR, n = 34; SIS, n = 26). There were 20 patients (59%) with recurrent HH in the PR group and 14 patients (54%) with recurrent HH in the SIS group (p = 0.7). There was no statistically significant difference in relevant symptoms or QOL between patients undergoing PR and SIS buttressed repair. There were no strictures, erosions, dysphagia, or other complications related to the use of SIS mesh.
Conclusions |
LPEHR results in long and durable relief of symptoms and improvement in QOL with PR or SIS. There does not appear to be a higher rate of complications or side effects with biologic mesh, but its benefit in reducing HH recurrence diminishes at long-term follow-up (more than 5 years postoperatively) or earlier.
Le texte complet de cet article est disponible en PDF.Abbreviations and Acronyms : HH, LPEHR, PPI, PR, QOL, SIS, UGI
Plan
| Disclosure Information: This work was supported in part by Cook Biotech. Dr Oelschlager received a research grant as a principal investigator for Cook Biotech; he is a program director and received educational grants from Covidien; he received a consulting fee as an instructor for Endogastric Solutions; and he received research grants as the principal investigator for the following companies: Takeda Pharmaceuticals, WL Gore, Torax, and Synovis. Dr Pellegrini's wife is an employee of Covidien, and he received grants as the principal investigator for Stryker, METI, and Cook. Dr Brunt received honoraria for speaking and teaching from Cook Medical and Lifecell Corp. Dr Swanstrom is a paid consultant for Boston Scientific, USGI, Olympus, and Virtual Port, and receives research and education support from Wolf, Ethicon, and Covidien. All other authors have nothing to disclose. |
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| This work was supported in part by the Mary and Dennis Wise Fund, University of Washington, Seattle, WA. |
Vol 213 - N° 4
P. 461-468 - octobre 2011 Retour au numéro
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