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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Terminated
CT.gov ID
NCT02770703
Collaborator
(none)
60
1
3
35
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DynaMesh visible mesh
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mesh Position and Outcomes Following Open (Lichtenstein), Endoscopic (TEP) and Laparoscopic (TAPP) Inguinal Hernia Repair Using a MRI Visible Hernia Mesh
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Mesh Position per MRI [90 days postoperatively]

Secondary Outcome Measures

  1. Evaluation of Mesh Deformation per MRI [90 days postoperatively]

  2. Groin pain using visual analogue scale [0, 1, 90, 365 days postoperatively]

  3. Recurrence of hernia [0, 1, 90, 365 days postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Basel, Department of Surgery Basel Switzerland 4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02770703
Other Study ID Numbers:
  • BASEC 2016-00085
First Posted:
May 12, 2016
Last Update Posted:
Mar 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2022