<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233569</url>
  </required_header>
  <id_info>
    <org_study_id>PHvsVS</org_study_id>
    <nct_id>NCT02233569</nct_id>
  </id_info>
  <brief_title>Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair</brief_title>
  <official_title>COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polish Hernia Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polish Hernia Study Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a monocenter randomized controlled trial comparing two systems of mesh and fixation&#xD;
      device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has&#xD;
      been designed as a superiority study to proof the concept of previously published&#xD;
      mathematical model of front abdominal wall.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The high recurrence rate and the findings during the reoperations were considered as serious&#xD;
    adverse events and were the reason for study termination.&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>7 days after the surgery</time_frame>
    <description>Presence of pain 7 days after the surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain</measure>
    <time_frame>3 months after the surgery</time_frame>
    <description>Presence of pain 3 months after the surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Recurrences</measure>
    <time_frame>up to one year</time_frame>
    <description>The recurrence rate in one year followup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with complications.</measure>
    <time_frame>up to one year</time_frame>
    <description>The description and percentage distribution of short and long term complications following surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>7 days after the surgery</time_frame>
    <description>Intensity of pain measured on a visual analogue scale 7 days after the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>30 days after the surgery</time_frame>
    <description>Intensity of pain measured on a visual analogue scale 30 days after the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>3 months after the surgery</time_frame>
    <description>Intensity of pain measured on a visual analogue scale 3 months after the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>6 months after the surgery</time_frame>
    <description>Intensity of pain measured on a visual analogue scale 6 months after the surgery.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time of the operation</measure>
    <time_frame>intraoperative</time_frame>
    <description>The duration of the surgical procedure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hernia, Abdominal</condition>
  <condition>Hernia,Ventral</condition>
  <arm_group>
    <arm_group_label>PH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.</intervention_name>
    <description>Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)</description>
    <arm_group_label>PH</arm_group_label>
    <other_name>ETHICON PHYSIOMESH® Flexible Composite Mesh</other_name>
    <other_name>ETHICON SECURESTRAP® Fixation Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.</intervention_name>
    <description>Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)</description>
    <arm_group_label>VS</arm_group_label>
    <other_name>BARD DAVOL INC.</other_name>
    <other_name>VENTRALIGHT™ ST Mesh</other_name>
    <other_name>Proven Sepra® Technology in a Low Profile, Lightweight Mesh</other_name>
    <other_name>ECHO PS™ Positioning System</other_name>
    <other_name>SORBAFIX™Absorbable Fixation System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventralight ST implant</intervention_name>
    <arm_group_label>VS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ETHICON PHYSIOMESH®</intervention_name>
    <arm_group_label>PH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent Form (ICF) signed by the patient or his/her legal representative&#xD;
&#xD;
          -  primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in&#xD;
             width requiring elective surgical repair&#xD;
&#xD;
          -  recurrence after former abdominal hernia repair WITH MESH&#xD;
&#xD;
          -  recurrence after suture abdominal hernia repair CAN be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no written informed consent&#xD;
&#xD;
          -  patient under 18 years old&#xD;
&#xD;
          -  emergency surgery (incarcerated hernia)&#xD;
&#xD;
          -  patients with expected life time shorter than one year for example due to generalised&#xD;
             malignancy&#xD;
&#xD;
          -  BMI exceeding 40.0kg/m²&#xD;
&#xD;
          -  contaminated surgical fields&#xD;
&#xD;
          -  patients on immunosuppression, steroid therapy, constant pain therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maciej Pawlak, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_official>
    <last_name>Maciej Śmietański, PhD</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Ceynowa Hospital</name>
      <address>
        <city>Wejherowo</city>
        <state>Pomorskie</state>
        <zip>84-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, Guleria S, Arora MK, Chabra A. A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc. 2011 May;25(5):1431-8. doi: 10.1007/s00464-010-1410-6. Epub 2010 Oct 26.</citation>
    <PMID>20976495</PMID>
  </reference>
  <reference>
    <citation>Beldi G, Wagner M, Bruegger LE, Kurmann A, Candinas D. Mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation. Surg Endosc. 2011 Mar;25(3):749-55. doi: 10.1007/s00464-010-1246-0. Epub 2010 Jul 23.</citation>
    <PMID>20652715</PMID>
  </reference>
  <reference>
    <citation>Bellows CF, Berger DH. Infiltration of suture sites with local anesthesia for management of pain following laparoscopic ventral hernia repairs: a prospective randomized trial. JSLS. 2006 Jul-Sep;10(3):345-50.</citation>
    <PMID>17212893</PMID>
  </reference>
  <reference>
    <citation>Byrd JF, Agee N, Swan RZ, Lau KN, Heath JJ, Mckillop IH, Sindram D, Martinie JB, Iannitti DA. Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. Hernia. 2011 Oct;15(5):553-8. doi: 10.1007/s10029-011-0826-9. Epub 2011 May 19.</citation>
    <PMID>21594698</PMID>
  </reference>
  <reference>
    <citation>Carter SA, Hicks SC, Brahmbhatt R, Liang MK. Recurrence and pseudorecurrence after laparoscopic ventral hernia repair: predictors and patient-focused outcomes. Am Surg. 2014 Feb;80(2):138-48.</citation>
    <PMID>24480213</PMID>
  </reference>
  <reference>
    <citation>Chelala E, Debardemaeker Y, Elias B, Charara F, Dessily M, Alle JL. Eighty-five redo surgeries after 733 laparoscopic treatments for ventral and incisional hernia: adhesion and recurrence analysis. Hernia. 2010 Apr;14(2):123-9. doi: 10.1007/s10029-010-0637-4. Epub 2010 Feb 14.</citation>
    <PMID>20155431</PMID>
  </reference>
  <reference>
    <citation>Clarke T, Katkhouda N, Mason RJ, Cheng BC, Algra J, Olasky J, Sohn HJ, Moazzez A, Balouch M. Fibrin glue for intraperitoneal laparoscopic mesh fixation: a comparative study in a swine model. Surg Endosc. 2011 Mar;25(3):737-48. doi: 10.1007/s00464-010-1244-2. Epub 2010 Jul 31.</citation>
    <PMID>20680350</PMID>
  </reference>
  <reference>
    <citation>Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair. Surg Endosc. 2011 May;25(5):1541-52. doi: 10.1007/s00464-010-1432-0. Epub 2010 Oct 26.</citation>
    <PMID>20976479</PMID>
  </reference>
  <reference>
    <citation>Deeken CR, Matthews BD. Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. JSLS. 2013 Oct-Dec;17(4):549-59. doi: 10.4293/108680813X13693422520125.</citation>
    <PMID>24398196</PMID>
  </reference>
  <reference>
    <citation>Eriksen JR, Bech JI, Linnemann D, Rosenberg J. Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel) vs. titanium tacks: a randomised controlled experimental study in pigs. Hernia. 2008 Oct;12(5):483-91. doi: 10.1007/s10029-008-0375-z. Epub 2008 May 16.</citation>
    <PMID>18483783</PMID>
  </reference>
  <reference>
    <citation>Eriksen JR, Poornoroozy P, Jorgensen LN, Jacobsen B, Friis-Andersen HU, Rosenberg J. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia. 2009 Feb;13(1):13-21. doi: 10.1007/s10029-008-0414-9. Epub 2008 Aug 1.</citation>
    <PMID>18670733</PMID>
  </reference>
  <reference>
    <citation>Hanna EM, Voeller GR, Roth JS, Scott JR, Gagne DH, Iannitti DA. Evaluation of ECHO PS Positioning System in a Porcine Model of Simulated Laparoscopic Ventral Hernia Repair. ISRN Surg. 2013 May 23;2013:862549. doi: 10.1155/2013/862549. Print 2013.</citation>
    <PMID>23762628</PMID>
  </reference>
  <reference>
    <citation>Liang MK, Clapp M, Li LT, Berger RL, Hicks SC, Awad S. Patient Satisfaction, chronic pain, and functional status following laparoscopic ventral hernia repair. World J Surg. 2013 Mar;37(3):530-7. doi: 10.1007/s00268-012-1873-9.</citation>
    <PMID>23212794</PMID>
  </reference>
  <reference>
    <citation>Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.</citation>
    <PMID>19495920</PMID>
  </reference>
  <reference>
    <citation>Smietanski M, Bigda J, Iwan K, Kolodziejczyk M, Krajewski J, Smietanska IA, Gumiela P, Bury K, Bielecki S, Sledzinski Z. Assessment of usefulness exhibited by different tacks in laparoscopic ventral hernia repair. Surg Endosc. 2007 Jun;21(6):925-8. doi: 10.1007/s00464-006-9055-1. Epub 2007 Jan 23.</citation>
    <PMID>17242988</PMID>
  </reference>
  <reference>
    <citation>Szymczak C, Lubowiecka I, Tomaszewska A, Smietanski M. Investigation of abdomen surface deformation due to life excitation: implications for implant selection and orientation in laparoscopic ventral hernia repair. Clin Biomech (Bristol, Avon). 2012 Feb;27(2):105-10. doi: 10.1016/j.clinbiomech.2011.08.008. Epub 2011 Sep 15.</citation>
    <PMID>21920647</PMID>
  </reference>
  <reference>
    <citation>Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24.</citation>
    <PMID>20033726</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Polish Hernia Study Group</investigator_affiliation>
    <investigator_full_name>Maciej Pawlak</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic hernia repair</keyword>
  <keyword>Ventral hernia</keyword>
  <keyword>Incisional hernia</keyword>
  <keyword>IPOM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233569
org study id: PHvsVS
nct id: NCT02233569
lead sponsor: 
has dmc: Yes
This is a monocenter randomized controlled trial comparing two systems of mesh and fixation
      device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has
      been designed as a superiority study to proof the concept of previously published
      mathematical model of front abdominal wall.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain
time frame: 7 days after the surgery
description: Presence of pain 7 days after the surgery.
measure: Pain
time frame: 3 months after the surgery
description: Presence of pain 3 months after the surgery.
measure: Number of Participants with Recurrences
time frame: up to one year
description: The recurrence rate in one year followup.
measure: Number of Participants with complications.
time frame: up to one year
description: The description and percentage distribution of short and long term complications following surgery.
measure: Pain intensity
time frame: 7 days after the surgery
description: Intensity of pain measured on a visual analogue scale 7 days after the surgery
measure: Pain intensity
time frame: 30 days after the surgery
description: Intensity of pain measured on a visual analogue scale 30 days after the surgery
measure: Pain intensity
time frame: 3 months after the surgery
description: Intensity of pain measured on a visual analogue scale 3 months after the surgery.
measure: Pain intensity
time frame: 6 months after the surgery
description: Intensity of pain measured on a visual analogue scale 6 months after the surgery.
measure: Time of the operation
time frame: intraoperative
description: The duration of the surgical procedure
arm group label: PH
arm group type: Active Comparator
description: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
arm group label: VS
arm group type: Active Comparator
description: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
intervention type: Procedure
intervention name: Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.
description: Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
arm group label: PH
other name: ETHICON PHYSIOMESH® Flexible Composite Mesh
other name: ETHICON SECURESTRAP® Fixation Device
intervention type: Procedure
intervention name: Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.
description: Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)
arm group label: VS
other name: BARD DAVOL INC.
other name: VENTRALIGHT™ ST Mesh
other name: Proven Sepra® Technology in a Low Profile, Lightweight Mesh
other name: ECHO PS™ Positioning System
other name: SORBAFIX™Absorbable Fixation System
intervention type: Device
intervention name: Ventralight ST implant
arm group label: VS
intervention type: Device
intervention name: ETHICON PHYSIOMESH®
arm group label: PH
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Maciej Pawlak, MD
role: Principal Investigator
last name: Maciej Śmietański, PhD
role: Study Director
facility: 
country: Poland
citation: Bansal VK, Misra MC, Kumar S, Rao YK, Singhal P, Goswami A, Guleria S, Arora MK, Chabra A. A prospective randomized study comparing suture mesh fixation versus tacker mesh fixation for laparoscopic repair of incisional and ventral hernias. Surg Endosc. 2011 May;25(5):1431-8. doi: 10.1007/s00464-010-1410-6. Epub 2010 Oct 26.
PMID: 20976495
citation: Beldi G, Wagner M, Bruegger LE, Kurmann A, Candinas D. Mesh shrinkage and pain in laparoscopic ventral hernia repair: a randomized clinical trial comparing suture versus tack mesh fixation. Surg Endosc. 2011 Mar;25(3):749-55. doi: 10.1007/s00464-010-1246-0. Epub 2010 Jul 23.
PMID: 20652715
citation: Bellows CF, Berger DH. Infiltration of suture sites with local anesthesia for management of pain following laparoscopic ventral hernia repairs: a prospective randomized trial. JSLS. 2006 Jul-Sep;10(3):345-50.
PMID: 17212893
citation: Byrd JF, Agee N, Swan RZ, Lau KN, Heath JJ, Mckillop IH, Sindram D, Martinie JB, Iannitti DA. Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength. Hernia. 2011 Oct;15(5):553-8. doi: 10.1007/s10029-011-0826-9. Epub 2011 May 19.
PMID: 21594698
citation: Carter SA, Hicks SC, Brahmbhatt R, Liang MK. Recurrence and pseudorecurrence after laparoscopic ventral hernia repair: predictors and patient-focused outcomes. Am Surg. 2014 Feb;80(2):138-48.
PMID: 24480213
citation: Chelala E, Debardemaeker Y, Elias B, Charara F, Dessily M, Alle JL. Eighty-five redo surgeries after 733 laparoscopic treatments for ventral and incisional hernia: adhesion and recurrence analysis. Hernia. 2010 Apr;14(2):123-9. doi: 10.1007/s10029-010-0637-4. Epub 2010 Feb 14.
PMID: 20155431
citation: Clarke T, Katkhouda N, Mason RJ, Cheng BC, Algra J, Olasky J, Sohn HJ, Moazzez A, Balouch M. Fibrin glue for intraperitoneal laparoscopic mesh fixation: a comparative study in a swine model. Surg Endosc. 2011 Mar;25(3):737-48. doi: 10.1007/s00464-010-1244-2. Epub 2010 Jul 31.
PMID: 20680350
citation: Deeken CR, Abdo MS, Frisella MM, Matthews BD. Physicomechanical evaluation of absorbable and nonabsorbable barrier composite meshes for laparoscopic ventral hernia repair. Surg Endosc. 2011 May;25(5):1541-52. doi: 10.1007/s00464-010-1432-0. Epub 2010 Oct 26.
PMID: 20976479
citation: Deeken CR, Matthews BD. Ventralight ST and SorbaFix versus Physiomesh and Securestrap in a porcine model. JSLS. 2013 Oct-Dec;17(4):549-59. doi: 10.4293/108680813X13693422520125.
PMID: 24398196
citation: Eriksen JR, Bech JI, Linnemann D, Rosenberg J. Laparoscopic intraperitoneal mesh fixation with fibrin sealant (Tisseel) vs. titanium tacks: a randomised controlled experimental study in pigs. Hernia. 2008 Oct;12(5):483-91. doi: 10.1007/s10029-008-0375-z. Epub 2008 May 16.
PMID: 18483783
citation: Eriksen JR, Poornoroozy P, Jorgensen LN, Jacobsen B, Friis-Andersen HU, Rosenberg J. Pain, quality of life and recovery after laparoscopic ventral hernia repair. Hernia. 2009 Feb;13(1):13-21. doi: 10.1007/s10029-008-0414-9. Epub 2008 Aug 1.
PMID: 18670733
citation: Hanna EM, Voeller GR, Roth JS, Scott JR, Gagne DH, Iannitti DA. Evaluation of ECHO PS Positioning System in a Porcine Model of Simulated Laparoscopic Ventral Hernia Repair. ISRN Surg. 2013 May 23;2013:862549. doi: 10.1155/2013/862549. Print 2013.
PMID: 23762628
citation: Liang MK, Clapp M, Li LT, Berger RL, Hicks SC, Awad S. Patient Satisfaction, chronic pain, and functional status following laparoscopic ventral hernia repair. World J Surg. 2013 Mar;37(3):530-7. doi: 10.1007/s00268-012-1873-9.
PMID: 23212794
citation: Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.
PMID: 19495920
citation: Smietanski M, Bigda J, Iwan K, Kolodziejczyk M, Krajewski J, Smietanska IA, Gumiela P, Bury K, Bielecki S, Sledzinski Z. Assessment of usefulness exhibited by different tacks in laparoscopic ventral hernia repair. Surg Endosc. 2007 Jun;21(6):925-8. doi: 10.1007/s00464-006-9055-1. Epub 2007 Jan 23.
PMID: 17242988
citation: Szymczak C, Lubowiecka I, Tomaszewska A, Smietanski M. Investigation of abdomen surface deformation due to life excitation: implications for implant selection and orientation in laparoscopic ventral hernia repair. Clin Biomech (Bristol, Avon). 2012 Feb;27(2):105-10. doi: 10.1016/j.clinbiomech.2011.08.008. Epub 2011 Sep 15.
PMID: 21920647
citation: Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24.
PMID: 20033726
responsible party type: Principal Investigator
investigator affiliation: Polish Hernia Study Group
investigator full name: Maciej Pawlak
investigator title: MD
mesh term: Hernia
mesh term: Incisional Hernia
mesh term: Hernia, Ventral
mesh term: Hernia, Abdominal
mesh term: Internal Hernia