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

• ClinicalTrials.gov Identifier: NCT05678465
• Recruitment Status: Recruiting
• First Posted: January 10, 2023
• Last Update Posted: April 17, 2024
• Sponsor: Swissmed Hospital
• 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; Oddział Chirurgiczny Ogólny, Wojewódzki Szpital Specjalistyczny w Częstochowie
• Information provided by (Responsible Party): Mateusz Zamkowski, Swissmed Hospital

Study Description

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

Detailed Description:

INTRODUCTION International guidelines of groin hernia treatment strongly recommends to fixate the mesh in case of large M3 medial defects during laparoendoscopic approach (TAPP / TEP). Main purpose of fixation is to decrease recurrence rate which is alarmingly high in case of those defects. Recommendation was based on analysis of large German database (Herniamed). However, deeper look into those findings shows that most of TAPP and TEP procedures were performed with the use of lightweight, flat, macroporous meshes. In 2022 multidisciplinary team consisting of hernia surgeons and scientists from universities of technology conducted an experimental study with the use of 3d groin model to confirm or deny the hypothesis that fixation is not necessary in above cases. Study was conducted with the use of all 3-D anatomical meshes available on Polish market, as well as with flat, macroporous implants. Experiment showed that large, rigid and anatomically shaped meshes are able to maintain its position in groin without need of fixation. To confirm experimental results we decided to conduct large, multicentre, clinical study to evaluate necessity of mesh fixation of large, spatial, standard polypropylene implants.

STUDY HYPOTHESIS Non-fixation of spatial, standard polypropylene meshes is non-inferior as compared to fixation of flat, polypropylene lightweight meshes during TAPP / TEP procedures.

MATERIALS AND METHODS 11 large surgery centres in Poland having proficiency in laparoendoscopic groin hernia repairs (performing at least 80 TAPP/TEP a year) were recruited for this study. Before recruiting patients a two day "bootcamp" meeting was planned. Each centre designated one surgeon responsible for conducing the trial in its hospital and sent him/her to meeting. Recurrence rate in 12-month follow-up was set as a primary endpoint. Pain sensation (assessed with VAS scale) was made a secondary endpoint. Statistical analysis was performed by experts to adjust the sample sizes. The trial was planned as non-inferiority study with test power = 80%, p-value = 0,05 and threshold for clinical significance = 8%. Percentage loss was assumed at 10%. Recurrence rate was assumed 4% based on literature. Based on those assumptions minimal sample size in both arms was calculated at 83-102. Inclusion criteria: elective groin hernia repair, age > 18 years, male and female patients can participate, M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery, eligibility to laparoendoscopic repair, written informed consent. Exclusion criteria: age <18 years, emergency surgery (incarcerated hernia), contaminated surgical field, extremely large scrotal hernia with the need of other forms of prevention of ACS (preoperative botox injection, bowel resection etc.) First arm (control group) will consist of patients repaired with the use of flat, macroporous, lightweight mesh fixated with histoacryl glue. Second arm will consist of patients repaired with the use of anatomically shaped, large, standard, polypropylene mesh (Dextile Anatomical Mesh - MEDTRONIC or 3D Max Mesh - BD) without the use of fixation material.

As M3 hernias are difficult to diagnose before the surgery, all patients planned for laparoendscopic repairs will be asked to participate in trial. During the surgery, when the defect size is measured, patient will be fully included in the study. After dissection of preperitoneal space (and establishing crucial checkpoints), surgeon will open envelope and find out the technique he will have to perform. Patients won't be aware of the method used during surgery. Unblinding will take place at the end of the trial. Pain will be measured during the hospital stay and then 7-days, 3-months and 12-months after surgery (VAS Scale). Follow up will be performed by Medical Assistant via phone call (also blinded to the method used). If any doubts occur, patient will be asked to come to ambulatory visit.

PREDICTED OUTCOMES Based on experimental study published in Surgical Endoscopy (Zamkowski et al., 2022) and own experience, we believe that recurrence rate in both arms will be on the same level. Those outcomes will be a strong argument for amending the guidelines in terms of mesh fixation. It would show that mesh fixation is not necessary if the proper, spatial mesh is used.

Study Design

• 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
• Actual Primary Completion Date: January 1, 2024
• Estimated Study Completion Date: January 1, 2025

Arms and Interventions

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)

Outcome Measures

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.)

Eligibility Criteria

• 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.)

Contacts and Locations

Contacts

Contact: Mateusz Zamkowski, MD, PhD; +48 504 236 036; zamek@wp.eu

Contact: Magda Halska; + 48 607 870 690; worldofsurge@gmail.com

Locations

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

Oddział Chirurgiczny Ogólny, Wojewódzki Szpital Specjalistyczny w Częstochowie

Investigators

• Study Chair: Mateusz Zamkowski, MD, PhD; Swissmed Hospital
• Study Director: Maciej Śmietański, Prof.; Swissmed Hospital

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Mateusz Zamkowski, MD, PhD, Swissmed Hospital
• ClinicalTrials.gov Identifier: NCT05678465
• Other Study ID Numbers: MEFI TRIAL
• First Posted: January 10, 2023
• Last Update Posted: April 17, 2024
• Last Verified: April 2024

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.

• 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:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal