Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh

Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh

Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned.

Two of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control.

Until now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery.

In this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.

Study Overview

• Status: Terminated
• Conditions: Unilateral Simple Inguinal Hernia
• Intervention / Treatment: Device: DynaMesh visible mesh

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital of Basel, Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male patients with a primary symptomatic unilateral inguinal hernia.
• Patients eligible to undergo hernia repair either by minimally invasive (TEP, TAPP) or open techniques (e.g. Lichtenstein) as judged by the treating surgeon
• Written informed consent

Exclusion Criteria:

• Previous inguinal hernia repair
• Bilateral inguinal hernia
• Femoral hernia repair
• Repair in local anesthetics,
• Previous abdominal surgery
• Children
• Emergency surgery, e.g. incarcerated hernias
• Contraindication for MRI scans (e.g. Pacemakers and similar implants, cochlea implants, claustrophobia)
• Contraindications to usage of mesh e.g. known hypersensitivity or allergy
• Women who are pregnant or breast feeding
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
• American Society of Anesthesiologists (ASA) classification higher or equal to 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open inguinal hernia repair (Lichtenstein); Open inguinal hernia repair using a DynaMesh visible mesh	Device: DynaMesh visible mesh; Implantation of a MRI visible mesh
Experimental: Total extraperitoneal inguinal hernia repair (TEP); Total extraperitoneal inguinal hernia repair using a DynaMesh visible mesh	Device: DynaMesh visible mesh; Implantation of a MRI visible mesh
Experimental: Trans abdominal preperitoneal hernia repair (TAPP); Trans abdominal preperitoneal hernia repair using a DynaMesh visible mesh	Device: DynaMesh visible mesh; Implantation of a MRI visible mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of Mesh Position per MRI	90 days postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of Mesh Deformation per MRI	90 days postoperatively
Groin pain using visual analogue scale	0, 1, 90, 365 days postoperatively
Recurrence of hernia	0, 1, 90, 365 days postoperatively

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Robert Mechera, MD, University Hospital of Basel, Department of Surgery

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: BASEC 2016-00085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No