Universität zu Köln

Miserez, Marc, Lefering, Rolf, Famiglietti, Federico, Mathes, Tim, Seidel, Dorthe, Sauerland, Stefan, Korolija, Dragan, Heiss, Markus, Weber, Gyorgy, Agresta, Ferdinando ORCID: 0000-0002-6114-1881, Steup, Willem-Hans, smietanski, Maciej, Ribeiro, Rui ORCID: 0000-0003-4150-2325, Cuccurullo, Diego, Catena, Fausto, Rudroff, Claudia, Rosanelli, Georg, Schon, Fabian, Smet, Bart, Wenger, Frank, Saad, Stefano, Naver, Lars and Neugebauer, Edmund (2021). Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS) Results of a Multinational, Randomized, Controlled, and Double-blind Trial. Ann. Surg., 273 (1). S. 57 - 66. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1528-1140

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Abstract

Objective: The aim of this study was to investigate the approach (open or laparoscopic) and mesh type (synthetic or biological) in ventral hernias in a clean setting. Summary of Background Data: The level of evidence on the optimal surgical approach and type of mesh in ventral hernia repair is still low. Methods: Patients with a ventral abdominal hernia (diameter 4-10 cm) were included in this double-blind randomized controlled trial across 17 hospitals in 10 European countries. According to a 2 x 2-factorial design, patients were allocated to 4 arms (open retromuscular or laparoscopic intraperitoneal, with synthetic or Surgisis Gold biological mesh). Patients and outcome assessors were blinded to mesh type used. Major postoperative complication rate (hernia recurrence, mesh infection, or reoperation) within 3 years after surgery, was the primary endpoint in the intention-to-treat population. Results: Between September 1st, 2005, and August 7th, 2009, 253 patients were randomized and 13 excluded. Six of 61 patients (9.8%) in the open synthetic mesh arm, 15 of 66 patients (22.7%) in the open biological mesh arm, 7 of 64 patients (10.9%) in the laparoscopic synthetic mesh arm and 17 of 62 patients (27.4%) in the laparoscopic biological mesh arm had a major complication. The use of biological mesh resulted in significantly more complications (P = 0.013), also after adjusting for hernia type, body mass index, and study site. The trial was prematurely stopped due to an unacceptable high recurrence rate in the biological mesh arms. Conclusions: The use of Surgisis Gold biological mesh is not recommended for noncomplex ventral hernia repair.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Miserez, Marc UNSPECIFIED UNSPECIFIED UNSPECIFIED Lefering, Rolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Famiglietti, Federico UNSPECIFIED UNSPECIFIED UNSPECIFIED Mathes, Tim UNSPECIFIED UNSPECIFIED UNSPECIFIED Seidel, Dorthe UNSPECIFIED UNSPECIFIED UNSPECIFIED Sauerland, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Korolija, Dragan UNSPECIFIED UNSPECIFIED UNSPECIFIED Heiss, Markus UNSPECIFIED UNSPECIFIED UNSPECIFIED Weber, Gyorgy UNSPECIFIED UNSPECIFIED UNSPECIFIED Agresta, Ferdinando UNSPECIFIED orcid.org/0000-0002-6114-1881 UNSPECIFIED Steup, Willem-Hans UNSPECIFIED UNSPECIFIED UNSPECIFIED smietanski, Maciej UNSPECIFIED UNSPECIFIED UNSPECIFIED Ribeiro, Rui UNSPECIFIED orcid.org/0000-0003-4150-2325 UNSPECIFIED Cuccurullo, Diego UNSPECIFIED UNSPECIFIED UNSPECIFIED Catena, Fausto UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudroff, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosanelli, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Schon, Fabian UNSPECIFIED UNSPECIFIED UNSPECIFIED Smet, Bart UNSPECIFIED UNSPECIFIED UNSPECIFIED Wenger, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Saad, Stefano UNSPECIFIED UNSPECIFIED UNSPECIFIED Naver, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Neugebauer, Edmund UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-602802
DOI:	10.1097/SLA.0000000000004062
Journal or Publication Title:	Ann. Surg.
Volume:	273
Number:	1
Page Range:	S. 57 - 66
Date:	2021
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1528-1140
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Surgery Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/60280