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MEsh FIxation in Laparoendoscopic Repair of Large M3 Inguinal Hernias (MEFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05678465
Recruitment Status : Recruiting
First Posted : January 10, 2023
Last Update Posted : April 12, 2023
Sponsor:
Collaborators:
Klinika Chirurgii Ogólnej, Onkologicznej i Endokrynologicznej Szpitala Zespolonego w Kielcach
Oddział Chirurgii Ogólnej MCM Jonscher w Łodzi
Oddział Chirurgii Ogólnej i Onkologicznej Szpitala w Wejherowie
Klinika Chirurgii Ogólnej i Onkologicznej UM w Łodzi
Oddział Chirurgii Ogólnej, Małoinwazyjnej i Wieku Podeszłego Miejskiego Szpitala Zespolonego w Olsztynie
Oddział Chirurgii Ogólnej Regionalnego Centrum Zdrowia w Lubinie
Klinika Chirurgii Ogólnej, Wojskowy Instytut Medycyny Lotniczej w Warszawie
Oddział Chirurgii Ogólnej, SPOZ w Siedlcach
Oddział Chirurgii Ogólnej Szpitala w Puszczykowie
Oddział Chirurgii Ogólnej z Pododdziałem Urazowo-Ortopedycznym Szpitala w Szczytnie
Information provided by (Responsible Party):
Mateusz Zamkowski, Swissmed Hospital

Brief Summary:
The goal of this Multicenter Clinical Trial is to verify the hypothesis that non-fixation of the 3-D anatomical mesh (Dextile Anatomical Mesh or 3D Max Mesh) is non-inferior in terms of recurrence compared to fixation of lightweight, macroporous meshes in laparoendoscopic repairs of large M3 inguinal hernias.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Hernia, Direct Inguinal Procedure: Non-fixation of the mesh Procedure: Fixation of the mesh Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients in both arms will recieve intervention. First arm (mesh + fixation) serves also as control. Patients in second arm will be operated with mesh without fixation.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blinded (surgeon/patient)
Primary Purpose: Treatment
Official Title: MEsh FIxation in Laparoendoscopic Repair of Large M3 Inguinal Hernias - Multicenter, Double-blinded, Randomized Controlled Trial.
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: FIXATION

Lightweight macroporous mesh at least 15x10cm will be placed in preperitoneal space and fixated with use of histoacryl glue.

Mesh - B Braun® Optilene Mesh® or BD® SoftMesh® Glue - Histoacryl® LapFix

Procedure: Fixation of the mesh
Glue fixation of lightweight, macroporous, polypropylene mesh.
Other Names:
  • B Braun Optilene Mesh
  • BD SoftMesh

Experimental: NON-FIXATION

Standard, 3-D, anatomical mesh will be placed in preperitoneal space without the use of fixating materials.

Mesh - BD® 3D Max® Mesh or Medtronic® Dextile Anatomical Mesh®

Procedure: Non-fixation of the mesh
3D-shaped, anatomical, standard, polypropylene mesh without fixation.
Other Names:
  • 3D Max Mesh (BD)
  • Dextile Anatomical Mesh (Medtronic)




Primary Outcome Measures :
  1. Reccurence Rate [ Time Frame: 12-months ]
    Reccurence in 1 year after surgery


Other Outcome Measures:
  1. Pain score [ Time Frame: 7-days, 3-months, 12-months ]
    Pain sensation using Pain Visual Analog Scale (VAS)

  2. Other complications [ Time Frame: 7-days, 3-months, 12-months ]
    Other surgical complications (seroma, hematoma, surgical site infections - SSI etc.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective groin hernia repair,
  • M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery
  • eligibility to laparoendoscopic repair
  • written informed consent

Exclusion Criteria:

  • emergency surgery (incarcerated hernia)
  • contaminated surgical field
  • recurrent hernia
  • extremely large scrotal hernia with the need of other forms of prevention of Abdominal Compartment Syndrome (botox injection, preoperative progressive pneumoperitoneum - PPP, bowel resection etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05678465


Contacts
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Contact: Mateusz Zamkowski, MD, PhD +48 504 236 036 zamek@wp.eu
Contact: Magda Halska + 48 607 870 690 worldofsurge@gmail.com

Locations
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Poland
Swissmed Hospital Recruiting
Gdańsk, Poland, 80-280
Contact: Mateusz Zamkowski, MD, PhD    + 48 504 236 036    zamek@wp.eu   
Contact: Magdalena Halska    +48 607 870 690    worldofsurge@gmail.com   
Sub-Investigator: Kryspin Mitura, MD, PhD         
Sub-Investigator: Przemysław Rymkiewicz, MD         
Sub-Investigator: Sławomir Saluk, MD         
Sub-Investigator: Michał Romańczuk, MD         
Sub-Investigator: Marcin Włodarczyk, MD, PhD         
Sub-Investigator: Aleksander Król, MD, PhD         
Sub-Investigator: Olaf Mędraś, MD         
Sub-Investigator: Dominik Górski, MD         
Sub-Investigator: Paula Franczak, MD         
Sub-Investigator: Jacek Garbias, MD         
Sub-Investigator: Przemysław Sroczyński, MD         
Sub-Investigator: Łukasz Nawacki, MD, PhD         
Sub-Investigator: Michał Janik, MD, PhD         
Sponsors and Collaborators
Swissmed Hospital
Klinika Chirurgii Ogólnej, Onkologicznej i Endokrynologicznej Szpitala Zespolonego w Kielcach
Oddział Chirurgii Ogólnej MCM Jonscher w Łodzi
Oddział Chirurgii Ogólnej i Onkologicznej Szpitala w Wejherowie
Klinika Chirurgii Ogólnej i Onkologicznej UM w Łodzi
Oddział Chirurgii Ogólnej, Małoinwazyjnej i Wieku Podeszłego Miejskiego Szpitala Zespolonego w Olsztynie
Oddział Chirurgii Ogólnej Regionalnego Centrum Zdrowia w Lubinie
Klinika Chirurgii Ogólnej, Wojskowy Instytut Medycyny Lotniczej w Warszawie
Oddział Chirurgii Ogólnej, SPOZ w Siedlcach
Oddział Chirurgii Ogólnej Szpitala w Puszczykowie
Oddział Chirurgii Ogólnej z Pododdziałem Urazowo-Ortopedycznym Szpitala w Szczytnie
Investigators
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Study Chair: Mateusz Zamkowski, MD, PhD Swissmed Hospital
Study Director: Maciej Śmietański, Prof. Swissmed Hospital
Publications:
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Responsible Party: Mateusz Zamkowski, MD, PhD, Swissmed Hospital
ClinicalTrials.gov Identifier: NCT05678465    
Other Study ID Numbers: MEFI TRIAL
First Posted: January 10, 2023    Key Record Dates
Last Update Posted: April 12, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be availble in English on a reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be availble in English on a reasonable request.
Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mateusz Zamkowski, Swissmed Hospital:
hernia
tapp
inguinal hernia
laparoendscopic repair
groin hernia
mesh
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal