Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Miserez, M, Lefering, R, Famiglietti, F, Mathes, T, Seidel, D, Sauerland, S, Korolija, D, Heiss, M, Weber, G, Agresta, F, Steup, W-H, Śmietański, M, Ribeiro, R, Cuccurullo, D, Catena, F, Rudroff, C, Rosanelli, G, Schön, F, Smet, B, Wenger, F, Saad, S, Naver, L & Neugebauer, E 2021, 'Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial', Annals of Surgery, vol. 273, no. 1, pp. 57-65. https://doi.org/10.1097/SLA.0000000000004062

APA

Miserez, M., Lefering, R., Famiglietti, F., Mathes, T., Seidel, D., Sauerland, S., Korolija, D., Heiss, M., Weber, G., Agresta, F., Steup, W-H., Śmietański, M., Ribeiro, R., Cuccurullo, D., Catena, F., Rudroff, C., Rosanelli, G., Schön, F., Smet, B., ... Neugebauer, E. (2021). Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial. Annals of Surgery, 273(1), 57-65. https://doi.org/10.1097/SLA.0000000000004062

CBE

Miserez M, Lefering R, Famiglietti F, Mathes T, Seidel D, Sauerland S, Korolija D, Heiss M, Weber G, Agresta F, Steup W-H, Śmietański M, Ribeiro R, Cuccurullo D, Catena F, Rudroff C, Rosanelli G, Schön F, Smet B, Wenger F, Saad S, Naver L, Neugebauer E. 2021. Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial. Annals of Surgery. 273(1):57-65. https://doi.org/10.1097/SLA.0000000000004062

MLA

Vancouver

Author

Miserez, Marc ; Lefering, Rolf ; Famiglietti, Federico ; Mathes, Tim ; Seidel, Dörthe ; Sauerland, Stefan ; Korolija, Dragan ; Heiss, Markus ; Weber, Gyorgy ; Agresta, Ferdinando ; Steup, Willem-Hans ; Śmietański, Maciej ; Ribeiro, Rui ; Cuccurullo, Diego ; Catena, Fausto ; Rudroff, Claudia ; Rosanelli, Georg ; Schön, Fabian ; Smet, Bart ; Wenger, Frank ; Saad, Stefano ; Naver, Lars ; Neugebauer, Edmund. / Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS) : Results of a Multinational, Randomized, Controlled, and Double-blind Trial. In: Annals of Surgery. 2021 ; Vol. 273, No. 1. pp. 57-65.

Bibtex

@article{d0389f99f6b8455da78dd89d4445a9f8,
title = "Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS): Results of a Multinational, Randomized, Controlled, and Double-blind Trial",
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 × 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.TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).",
author = "Marc Miserez and Rolf Lefering and Federico Famiglietti and Tim Mathes and D{\"o}rthe Seidel and Stefan Sauerland and Dragan Korolija and Markus Heiss and Gyorgy Weber and Ferdinando Agresta and Willem-Hans Steup and Maciej {\'S}mieta{\'n}ski and Rui Ribeiro and Diego Cuccurullo and Fausto Catena and Claudia Rudroff and Georg Rosanelli and Fabian Sch{\"o}n and Bart Smet and Frank Wenger and Stefano Saad and Lars Naver and Edmund Neugebauer",
note = "Publisher Copyright: Copyright {\textcopyright} 2020 Wolters Kluwer Health, Inc. All rights reserved. Copyright: This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine",
year = "2021",
month = jan,
day = "1",
doi = "10.1097/SLA.0000000000004062",
language = "English",
volume = "273",
pages = "57--65",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams & Wilkins",
number = "1",

}

RIS

TY - JOUR

T1 - Synthetic Versus Biological Mesh in Laparoscopic and Open Ventral Hernia Repair (LAPSIS)

T2 - Results of a Multinational, Randomized, Controlled, and Double-blind Trial

AU - Miserez, Marc

AU - Lefering, Rolf

AU - Famiglietti, Federico

AU - Mathes, Tim

AU - Seidel, Dörthe

AU - Sauerland, Stefan

AU - Korolija, Dragan

AU - Heiss, Markus

AU - Weber, Gyorgy

AU - Agresta, Ferdinando

AU - Steup, Willem-Hans

AU - Śmietański, Maciej

AU - Ribeiro, Rui

AU - Cuccurullo, Diego

AU - Catena, Fausto

AU - Rudroff, Claudia

AU - Rosanelli, Georg

AU - Schön, Fabian

AU - Smet, Bart

AU - Wenger, Frank

AU - Saad, Stefano

AU - Naver, Lars

AU - Neugebauer, Edmund

N1 - Publisher Copyright: Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved. Copyright: This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine

PY - 2021/1/1

Y1 - 2021/1/1

N2 - 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 × 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.TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

AB - 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 × 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.TRIAL REGISTRATION: This trial was registered at controlled-trials.com (ISRCTN34532248).

UR - http://www.scopus.com/inward/record.url?scp=85098676152&partnerID=8YFLogxK

U2 - 10.1097/SLA.0000000000004062

DO - 10.1097/SLA.0000000000004062

M3 - Journal article

C2 - 33332873

VL - 273

SP - 57

EP - 65

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

IS - 1

ER -

ID: 61593364