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Medical device under development, not CE marked and not available for sale.
A parastomal hernia is a type of incisional hernia that occurs around a stoma, where part of the intestine pushes through the abdominal wall.
It can lead to discomfort, pain, difficulties in managing the stoma appliance, and, in some cases, complications such as bowel obstruction or strangulation.
This condition can significantly affect a patient’s quality of life and often requires surgical management.Parastomal hernia, as defined by the European Hernia Society (EHS), refers to the protrusion of abdominal contents through a defect in the abdominal wall created during stoma formation.
It is one of the most common late complications following stoma surgery, with an estimated incidence of over 30% within the first year, rising to more than 40% by the second year, and exceeding 50% beyond two years [133].
The incidence varies depending on the type of stoma, with the highest prevalence seen in end colostomies, ranging from 4% to 48% [134].
Parastomal hernias increase the risk of mechanical complications such as strangulation and bowel obstruction. They can also significantly impact quality of life due to pain, a sensation of heaviness, difficulties with stoma appliance management, and cosmetic concerns.
Société Française de Chirurgie Digestive – Gestion des Stomies digestives de l’adulte
Recommandations françaises 2023 – Publié le : 04/12/2023
[133] Antoniou SA, Agresta F, Garcia Alamino JM, et al. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia 2018;22:183—98.
[134] Carne PWG, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg 2003;90:784—93.
CELLIS ® Stoma 3D is an acellular dermal matrix currently under development, with characteristics similar to the rest of the CELLIS® range.
It stands out due to its 3D shape, specifically designed to:
CELLIS ® Stoma 3D is intended to prevent parastomal hernias in adult patients following stoma creation, by reinforcing weakened soft tissues and supporting the regeneration of connective tissue.
Existing clinical data on similar biological matrices suggest potential effectiveness in preventing parastomal hernias, although results remain heterogeneous depending on the materials, shapes, and techniques used.
Thanks to its funnel shape, CELLIS ® Stoma 3D could offer advantages similar to synthetic devices while benefiting from better management of postoperative infections. However, specific clinical studies will be necessary to confirm its performance and validate its long-term safety.