NCT05678465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

December 26, 2022

Last Update Submit

October 12, 2024

Conditions

Hernia, InguinalHernia, Direct Inguinal

Keywords

herniatappinguinal hernialaparoendscopic repairgroin herniamesh

Outcome Measures

Primary Outcomes (1)

  • Reccurence Rate

    Reccurence in 1 year after surgery

    12-months

Other Outcomes (2)

  • Pain score

    7-days, 3-months, 12-months

  • Other complications

    7-days, 3-months, 12-months

Study Arms (2)

FIXATION

EXPERIMENTAL

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

NON-FIXATION

EXPERIMENTAL

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

Interventions

Non-fixation of the meshPROCEDURE

3D-shaped, anatomical, standard, polypropylene mesh without fixation.

Also known as: 3D Max Mesh (BD), Dextile Anatomical Mesh (Medtronic)
NON-FIXATION
Fixation of the meshPROCEDURE

Glue fixation of lightweight, macroporous, polypropylene mesh.

Also known as: B Braun Optilene Mesh, BD SoftMesh
FIXATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swissmed Hospital

Gdansk, 80-280, Poland

Location

Related Publications (5)

  • Zamkowski M, Tomaszewska A, Lubowiecka I, Karbowski K, Smietanski M. Is mesh fixation necessary in laparoendoscopic techniques for M3 inguinal defects? An experimental study. Surg Endosc. 2023 Mar;37(3):1781-1788. doi: 10.1007/s00464-022-09699-5. Epub 2022 Oct 13.

    PMID: 36229552BACKGROUND

  • HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.

    PMID: 29330835BACKGROUND

  • Mayer F, Niebuhr H, Lechner M, Dinnewitzer A, Kohler G, Hukauf M, Fortelny RH, Bittner R, Kockerling F. When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases. Surg Endosc. 2016 Oct;30(10):4363-71. doi: 10.1007/s00464-016-4754-8. Epub 2016 Feb 17.

    PMID: 26886454BACKGROUND

  • Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.

    PMID: 35213495BACKGROUND

  • Zamkowski M, Smietanski M. MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial-study protocol for a MEFI Trial. Trials. 2023 Sep 5;24(1):572. doi: 10.1186/s13063-023-07601-9.

    PMID: 37670376DERIVED

MeSH Terms

Conditions

Hernia, InguinalHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mateusz Zamkowski, MD, PhD

    Swissmed Hospital

    STUDY CHAIR

  • Maciej Śmietański, Prof.

    Swissmed Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded (surgeon/patient)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 10, 2023

Study Start

February 1, 2023

Primary Completion

November 30, 2023

Study Completion

October 12, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Data will be availble in English on a reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations

PL(1)