Bilateral Laparoscopic Repair of Groin Hernias With One Large Self-fixating Mesh (ProGripTM)
Condition: Hernia; Recurrence; Quality of Life
MeSH terms: Hernia; Recurrence; Hernia, Inguinal
Study type: Observational

Summary: 
      Investigation of a bilateral inguinal hernia repair using one large self-fixating mesh
      covering both groins. Health outcomes are assessed using different questionaires with focus
      on urinary symptoms (with ICIQ-MLUTS score), the recurrence rate, postoperative pain
      measurement, and Quality of Life assessment with EuraHS-QoL and chronic pain monitoring for
      12 months.
    

Detailed description: 
      1. INTRODUCTION

           Evidence in groin hernia repair showed a significant reduction in recurrence rates since
           the introduction of mesh repair. Hence all current guidelines state that in surgical
           treatment of groin hernias in adults a mesh should be used.

           In laparoscopic groin hernia repair a mesh is positioned in the preperitoneal plane. Two
           techniques are commonly used. A transabdominal technique (TransAbdominal PrePeritoneal -
           TAPP), in which the preperitoneal plane is dissected throughout the abdomen, with a
           closure of the peritoneum after positioning of the mesh, and a preperitoneal technique
           (Totally ExtraPeritoneal - TEP) in which the peritoneum remains intact.

           Fixation of the mesh was originally performed by penetrating fixation, using staples or
           tackers. Alternative fixation with glue, self-fixating meshes or no mesh fixation at
           all, have been proposed to avoid the postoperative pain related to the penetrating
           fixation. Several studies were not able to show significant differences in recurrence
           rates between the different mesh fixation techniques. In general, sufficient overlap
           seems more important than fixation of the mesh. However, current guidelines state that
           tacker or suture fixation of the mesh for groin hernia should be avoided.

           Concerns are often raised about large medial hernias (EHS classification: M3) because
           the medial overlap of the mesh beyond the hernia defect is small. An overlap of less
           than 2-3 cm may lead to protrusion of the mesh in the hernia opening, and this risk is
           increased in large direct hernias. In general, the larger the hernia opening, the more
           overlapping there should be. Observational studies have shown a higher recurrence rate
           in the repair of direct (i.e. medial) hernias. In a recent consensus statement, Poelman
           et al. stated that diverse types of inguinal hernias (direct vs. indirect, large vs.
           small) should be distinguished and treated in a different way. Despite the fact that
           randomized trials did not differentiate between large or small hernias, they state that
           the use of a heavy weight mesh, mesh fixation or larger mesh size should be considered
           in case of large medial hernias.

           In repair of bilateral inguinal hernias, current guidelines state that laparoscopic
           treatment is the preferable approach, without clear advantage of TEP over TAPP or
           vice-versa. During transabdominal (TAPP) repair, evaluation and subsequent treatment of
           a contralateral hernia can be performed without additional incision and/or trocar
           placement. Whether one large mesh or two separate meshes with sufficient overlap should
           be used, remains unclear. The IEHS guidelines state that both options can be used.
           However, the recurrences detected after the use of two separate meshes suggest the
           presence of weaker zone at the midline, despite the overlap. On the other hand,
           application of one large mesh seems to be technically more difficult. In laparoscopic
           groin hernia repair, the mesh is placed in the anatomical space between pubic bone and
           bladder. Any type of mesh might therefore potentially influence the urinary bladder
           function. Until now it is not clear if these urinary symptoms will be different in
           patients with one large mesh compared to those with two overlapping meshes.

        2. AIM AND DESIGN OF THE STUDY Purpose of this study is the assessment urinary symptoms
           after bilateral repair using one large self-fixating mesh covering both groins in repair
           of bilateral inguinal hernias. Health outcomes are assessed using different
           questionaires with focus on urinary symptoms (with ICIQ-MLUTS score), the recurrence
           rate, postoperative pain measurement, and Quality of Life assessment with EuraHS-QoL and
           chronic pain monitoring for 12 months.

           A total of 100 male patients will be entered in the trial in AZ MARIA MIDDELARES, for
           which an inclusion period of 24 months is anticipated. Study inclusion will be based on
           clinical examination and/or ultrasonography. Informed Consent will be obtained
           pre-operatively.

        3. OPERATIVE STANDARD PROCEDURES A bilateral laparoscopic groin hernia repair will be
           performed, using one large self-fixating mesh (ProGripTM). in transabdominal (TAPP)
           approach or in totally extra-peritoneal (TEP) approach on all patients.

        4. FOLLOW-UP After receiving informed consent and planned surgery, patients will get
           invited for a standard clinical check-up (at 1 month en 12 months post-operatively) and
           for assessment of urinary symptoms using the ICIQ-MLUTS (International Consultation on
           Incontinence modular Questionnaire on Lower Urinary Tract Symptoms) at 1 month, 3 months
           en 12 months post-operatively.

           Recurrence rates will be based on clinical examination by the surgeon during follow-up.
           In case of uncertainty during clinical evaluation further investigation using
           ultrasonography and/or CT scan will be performed.

           Quality of Life, using the pre- and postoperative EuraHS-QoL score and postoperative
           pain using a VAS (Visual Analogue Scale) scale will be assessed during the clinical
           follow-up moments. Additional registration of pain medication used will be performed.

        5. DATA COLLECTION AND ANALYSIS All data related to the surgical procedure, patient
           comorbidities and the post-operative course will be documented prospectively. Anonymized
           data of all patients will be collected in the online platform EuraHS (European Registry
           of Abdominal Wall Hernias), developed by the scientific working of European Hernia
           Society EHS under a specific study account.

      A study specific CRF including the ICIQ-MLUTS, the EuraHS-QoL, the VAS (visual analog scale)
      and VRS (verbal rating scale will be provided by the trial secretariat and gathered by the
      study coordinator.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 adult patients, men only, ages between 18 and 80 years with a primary bilateral
        inguinal hernias will be included based on clinical examination and/or ultrasonography.