Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Recurrence

Hernia

Hernia, Ventral

Neoplastic Processes

Pathological Conditions, Anatomical

Hernia, Abdominal

Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.

Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.

Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.

Placing the resorbable mesh

Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.

Non-resorbable synthetic mesh.

Frederik Berrevoet, MD, PhD

Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.

The TIGR™ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.

The aim of this study is to compare TIGR™ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).

Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.

Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Clinical evaluation and ultrasound evaluation after 3 years post-surgery.

Clinical Examination to determine the recurrence rate.

Novus Scientific

University Hospital, Ghent

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Prostatic Neoplasms

Obesity

Prolapse

Pelvic Organ Prolapse

Obesity, Morbid

Genital Diseases, Female

Mediastinal Neoplasms

Hernia, Inguinal

Thymoma

Thymus Neoplasms

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Mediastinal Diseases

Thoracic Diseases

Respiratory Tract Diseases

Subjects scheduled to undergo robotic-assisted surgery

Robotic-assisted Surgery

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Clinical Investigation of the da Vinci Surgical System

A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Intuitive Surgical

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.	NCT01622725	Primary and Sec...	Placing the res... Non-resorbable ...	18 Years -	University Hospital, Ghent
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.	NCT01622725	Primary and Sec...	Placing the res... Non-resorbable ...	18 Years -	University Hospital, Ghent
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.	NCT01622725	Primary and Sec...	Placing the res... Non-resorbable ...	18 Years -	University Hospital, Ghent
Clinical Investigation of the da Vinci Surgical System	NCT05682742	Thymoma Mediastinal Tum... Gynecologic Dis... Gynecologic Can... Pelvic Organ Pr... Prostate Diseas... Prostate Cancer Inguinal Hernia Ventral Hernia Obesity, Morbid	Robotic-assiste...	21 Years -	Intuitive Surgical

Spots Global Cancer Trial Database for ventral hernia