Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial
Background Patients’ need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two...
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| Veröffentlicht in: | Surgical endoscopy 2016-03, Vol.30 (3), p.1188-1197 |
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| creator | Pawlak, Maciej Hilgers, Ralf-Dieter Bury, Kamil Lehmann, Andrzej Owczuk, Radosław Śmietański, Maciej |
| description | Background
Patients’ need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
Methods
A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.
Results
During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (
p
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| doi_str_mv | 10.1007/s00464-015-4329-0 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1767071255</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3973523341</sourcerecordid><originalsourceid>FETCH-LOGICAL-c508t-afd1e10715c1d29e3178484c488a8cdc7f24764d322941d4e6a23a666298fbcd3</originalsourceid><addsrcrecordid>eNp1kcFuFSEUhonR2NvqA7gxJG7cTAWGgRl35kZtkyZudE0oHLw0MzAC11afwMf23NxqTBNX_Anf-TjkJ-QFZ-ecMf2mMiaV7BgfOtmLqWOPyIZj6oTg42OyYVPPOqEneUJOa71hiE98eEpOhOL9hHlDfm3zstoSa040B9puM_UxBCiQGnU5OVhbPdwsUHfUJk9DvLMtIt7A7VL8tgcaE50tWnJ1eY2OfsfhYme6g5KipQVWG8tbigkFeYk_wR_creR5xthKtPMz8iTYucLz-_OMfPnw_vP2orv69PFy--6qcwMbW2eD58CZ5oPjXkzQcz3KUTo5jnZ03ukgpFbS90JMknsJyoreKqXENIZr5_sz8vroXUvG3WszS6wO5tkmyPtquFYa9WIYEH31AL3J-5JwO6Q0Z4qNvUCKHymH_68FgllLXGz5YTgzh5rMsSaDNZlDTYbhzMt78_56Af934k8vCIgjUPEqfYXyz9P_tf4Ghh-ewg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1771060832</pqid></control><display><type>article</type><title>Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Pawlak, Maciej ; Hilgers, Ralf-Dieter ; Bury, Kamil ; Lehmann, Andrzej ; Owczuk, Radosław ; Śmietański, Maciej</creator><creatorcontrib>Pawlak, Maciej ; Hilgers, Ralf-Dieter ; Bury, Kamil ; Lehmann, Andrzej ; Owczuk, Radosław ; Śmietański, Maciej</creatorcontrib><description>Background
Patients’ need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
Methods
A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.
Results
During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (
p
< 0.0001) and no difference after 7 days (
p
= 0. 7019). The pain intensity decreased significantly over time (
p
< 0.0001) and was significantly higher in the PH group (
p
< 0.0001).
Conclusions
Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.</description><identifier>ISSN: 0930-2794</identifier><identifier>EISSN: 1432-2218</identifier><identifier>DOI: 10.1007/s00464-015-4329-0</identifier><identifier>PMID: 26139491</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Abdomen ; Abdominal Surgery ; Adult ; Aged ; Aged, 80 and over ; Clinical trials ; Design ; Female ; Gastroenterology ; Gynecology ; Hepatology ; Hernia, Ventral - surgery ; Hernias ; Herniorrhaphy - instrumentation ; Herniorrhaphy - methods ; Humans ; Laparoscopy ; Laparoscopy - methods ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Pain ; Pain, Postoperative - etiology ; Proctology ; Prospective Studies ; Recurrence ; Surgery ; Surgical Mesh ; Visual Analog Scale</subject><ispartof>Surgical endoscopy, 2016-03, Vol.30 (3), p.1188-1197</ispartof><rights>Springer Science+Business Media New York 2015</rights><rights>Springer Science+Business Media New York 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c508t-afd1e10715c1d29e3178484c488a8cdc7f24764d322941d4e6a23a666298fbcd3</citedby><cites>FETCH-LOGICAL-c508t-afd1e10715c1d29e3178484c488a8cdc7f24764d322941d4e6a23a666298fbcd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00464-015-4329-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00464-015-4329-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26139491$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pawlak, Maciej</creatorcontrib><creatorcontrib>Hilgers, Ralf-Dieter</creatorcontrib><creatorcontrib>Bury, Kamil</creatorcontrib><creatorcontrib>Lehmann, Andrzej</creatorcontrib><creatorcontrib>Owczuk, Radosław</creatorcontrib><creatorcontrib>Śmietański, Maciej</creatorcontrib><title>Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial</title><title>Surgical endoscopy</title><addtitle>Surg Endosc</addtitle><addtitle>Surg Endosc</addtitle><description>Background
Patients’ need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
Methods
A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.
Results
During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (
p
< 0.0001) and no difference after 7 days (
p
= 0. 7019). The pain intensity decreased significantly over time (
p
< 0.0001) and was significantly higher in the PH group (
p
< 0.0001).
Conclusions
Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.</description><subject>Abdomen</subject><subject>Abdominal Surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Clinical trials</subject><subject>Design</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Gynecology</subject><subject>Hepatology</subject><subject>Hernia, Ventral - surgery</subject><subject>Hernias</subject><subject>Herniorrhaphy - instrumentation</subject><subject>Herniorrhaphy - methods</subject><subject>Humans</subject><subject>Laparoscopy</subject><subject>Laparoscopy - methods</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Pain</subject><subject>Pain, Postoperative - etiology</subject><subject>Proctology</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Surgery</subject><subject>Surgical Mesh</subject><subject>Visual Analog Scale</subject><issn>0930-2794</issn><issn>1432-2218</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kcFuFSEUhonR2NvqA7gxJG7cTAWGgRl35kZtkyZudE0oHLw0MzAC11afwMf23NxqTBNX_Anf-TjkJ-QFZ-ecMf2mMiaV7BgfOtmLqWOPyIZj6oTg42OyYVPPOqEneUJOa71hiE98eEpOhOL9hHlDfm3zstoSa040B9puM_UxBCiQGnU5OVhbPdwsUHfUJk9DvLMtIt7A7VL8tgcaE50tWnJ1eY2OfsfhYme6g5KipQVWG8tbigkFeYk_wR_creR5xthKtPMz8iTYucLz-_OMfPnw_vP2orv69PFy--6qcwMbW2eD58CZ5oPjXkzQcz3KUTo5jnZ03ukgpFbS90JMknsJyoreKqXENIZr5_sz8vroXUvG3WszS6wO5tkmyPtquFYa9WIYEH31AL3J-5JwO6Q0Z4qNvUCKHymH_68FgllLXGz5YTgzh5rMsSaDNZlDTYbhzMt78_56Af934k8vCIgjUPEqfYXyz9P_tf4Ghh-ewg</recordid><startdate>20160301</startdate><enddate>20160301</enddate><creator>Pawlak, Maciej</creator><creator>Hilgers, Ralf-Dieter</creator><creator>Bury, Kamil</creator><creator>Lehmann, Andrzej</creator><creator>Owczuk, Radosław</creator><creator>Śmietański, Maciej</creator><general>Springer US</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20160301</creationdate><title>Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial</title><author>Pawlak, Maciej ; Hilgers, Ralf-Dieter ; Bury, Kamil ; Lehmann, Andrzej ; Owczuk, Radosław ; Śmietański, Maciej</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c508t-afd1e10715c1d29e3178484c488a8cdc7f24764d322941d4e6a23a666298fbcd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Abdomen</topic><topic>Abdominal Surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Clinical trials</topic><topic>Design</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Gynecology</topic><topic>Hepatology</topic><topic>Hernia, Ventral - surgery</topic><topic>Hernias</topic><topic>Herniorrhaphy - instrumentation</topic><topic>Herniorrhaphy - methods</topic><topic>Humans</topic><topic>Laparoscopy</topic><topic>Laparoscopy - methods</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Pain</topic><topic>Pain, Postoperative - etiology</topic><topic>Proctology</topic><topic>Prospective Studies</topic><topic>Recurrence</topic><topic>Surgery</topic><topic>Surgical Mesh</topic><topic>Visual Analog Scale</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pawlak, Maciej</creatorcontrib><creatorcontrib>Hilgers, Ralf-Dieter</creatorcontrib><creatorcontrib>Bury, Kamil</creatorcontrib><creatorcontrib>Lehmann, Andrzej</creatorcontrib><creatorcontrib>Owczuk, Radosław</creatorcontrib><creatorcontrib>Śmietański, Maciej</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Surgical endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pawlak, Maciej</au><au>Hilgers, Ralf-Dieter</au><au>Bury, Kamil</au><au>Lehmann, Andrzej</au><au>Owczuk, Radosław</au><au>Śmietański, Maciej</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial</atitle><jtitle>Surgical endoscopy</jtitle><stitle>Surg Endosc</stitle><addtitle>Surg Endosc</addtitle><date>2016-03-01</date><risdate>2016</risdate><volume>30</volume><issue>3</issue><spage>1188</spage><epage>1197</epage><pages>1188-1197</pages><issn>0930-2794</issn><eissn>1432-2218</eissn><abstract>Background
Patients’ need to improve outcomes and to reduce the number of complications triggers the development of new materials and surgery concepts. Currently, there are many implants and fixation systems dedicated for intraperitoneal onlay mesh procedure. The aim of this study was to compare two different mesh/fixation system concepts (PH: Physiomesh/Securestrap and VS: Ventralight ST/SorbaFix) for laparoscopic ventral hernia repair with respect to pain.
Methods
A single-center, prospective, randomized study was designed to include 50 patients per group with a planned interim analysis for safety after 25 patients. The endpoints were pain occurrences and intensity, which was measured with the visual analogue scale 7 days, 30 days, 3 months and 6 months after surgery. The safety parameters included the number of recurrences and postoperative complications.
Results
During the interim analysis, the study was stopped due to safety reasons. We observed five (20 %) recurrences in the PH group in first 6 months and none in the VS group. We observed a significantly higher pain rate in the PH group after 3 months (
p
< 0.0001) and no difference after 7 days (
p
= 0. 7019). The pain intensity decreased significantly over time (
p
< 0.0001) and was significantly higher in the PH group (
p
< 0.0001).
Conclusions
Although this clinical trial was terminated prior to the preplanned recruitment goal, the obtained results from the enrolled patients indicate that the PH system associated with significantly greater hernia recurrences and postoperative pain compared with the VS system. This confirms the superiority of the elastic mesh concept, which may be a safer and more efficacious option for laparoscopic ventral hernia repairs.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>26139491</pmid><doi>10.1007/s00464-015-4329-0</doi><tpages>10</tpages></addata></record> |
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| ispartof | Surgical endoscopy, 2016-03, Vol.30 (3), p.1188-1197 |
| issn | 0930-2794 1432-2218 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Abdomen Abdominal Surgery Adult Aged Aged, 80 and over Clinical trials Design Female Gastroenterology Gynecology Hepatology Hernia, Ventral - surgery Hernias Herniorrhaphy - instrumentation Herniorrhaphy - methods Humans Laparoscopy Laparoscopy - methods Male Medicine Medicine & Public Health Middle Aged Pain Pain, Postoperative - etiology Proctology Prospective Studies Recurrence Surgery Surgical Mesh Visual Analog Scale |
| title | Comparison of two different concepts of mesh and fixation technique in laparoscopic ventral hernia repair: a randomized controlled trial |
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