Clinical studies

Every year, many patients take part in clinical research at the Maria Middelares General Hospital. Our centre has been specialising for several years in researching new and existing treatment methods. This research often takes place in collaboration with internal and external partners, on behalf of pharmaceutical companies or on our own initiative.

The voluntary cooperation of patients is essential to improve the quality of our service. The safety of the patients taking part in the study is always a top priority. If you qualify for a specific study, your surgeon may ask you to participate. You have complete freedom to decide whether you want this or not.

‘A patient, with respect for his or her human dignity and autonomy and without discrimination on any grounds whatsoever, has the right to a quality service that meets his or her needs.’

The term “clinical study” refers to all studies in patients as part of a scientific study. That is why a clinical study can be seen as a practical approach to a medical scientific question.
Clinical studies are taking place in all fields of research in hernia surgery. Sometimes they concern questionnaires submitted to participants or the retrieval of data from past surgeries (i.e. retrospective) or specific studies in patients after their operations (i.e. post-operative) and the testing of new treatment methods or medication, etc. (i.e. prospective).

Clinical studies are very important for the development or validation of new treatment therapies and techniques. Furthermore, clinical studies are essential in preventive health care. This is the purpose of registers such as the EuraHS register for the rupture of scar tissue, which help monitor certain diseases and their course or treatment. These registers make it possible to identify which patients are more at risk than others for certain conditions and where and when certain treatment methods should be started. In short, without the clinical studies, no progress in medicine is possible.

• Eugene study A randomised single-centre study on laparoscopic Groin hernia repair by a 3D endolap visible^TM with and without LiquiBand® Fix 8™ mesh fixation

With this study, we aim to demonstrate that the 3D Endolap mesh (or net) can be safely placed with or without fixation and to map the position of the mesh in the patient's body safely through an NMR examination at one month and at twelve months postoperatively.
The study patient will be followed up for five years post surgery.

Principle investigator: Dr Filip Muysoms
Research Centre: Maria Middelares General Hospital

• Coraline study: Conventional versus robot-assisted laparoscopic inguinal hernia repair (Coraline study)

Trial design: Prospective single-centre, double-blinded and randomised clinical trial

This study compares the postoperative course for patients after the laparoscopic repair of bilateral inguinal hernia treated with classical laparoscopic surgery (l-TAPP) to robot-assisted laparoscopic surgery (r-TAPP).
The study patient will be followed up for one year post surgery.

Principle investigator: Dr Filip Muysoms
Research Centre: Maria Middelares General Hospital

• PUMA study: Prospective cohort study on mesh shrinkage measured using MRI after robot-assisted laparoscopic preperitoneal mesh repair using an iron oxide loaded PVDF mesh (PUMA study: Pre-peritoneal Umbilical Mesh Area)

When repairing an abdominal wall fracture or hernia, a mesh (net) is always used so that the contents of the abdominal cavity can no longer move outside of the abdominal wall. Scientific evidence is lacking regarding the extent, if any, of net shrinkage after robot-assisted laparoscopic abdominal wall repair. This study attempts to demonstrate this by using mesh interwoven with iron particles (PVDF prosthesis) that are visible during an NMR examination. The study patients undergo NMR imaging at one month and thirteen months after their surgery to map the position and size of the mesh.

Principle investigator: Dr Filip Muysoms
Research Centre: Maria Middelares General Hospital

• rTARUP study: ‘long-term follow-up for two years after robot-assisted umbilical hernia repair’

Trial design: a single-centre prospective interventional cohort study

Referring to the retrospective study in which potential complications and recurrences were analysed at one year postoperatively (MMS.2021.021: long-term analysis of the rTARUP technique for ventral hernia repair), this study period was extended to a two-year follow-up period, so that more data are available on the long-term effects after rTARUP surgery.

Principle investigator: Dr Filip Muysoms
Research Centre: Maria Middelares General Hospital