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Search / Trial NCT06533839

Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh

Launched by CONSORCI SANITARI INTEGRAL · Jul 30, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Parastomal Hernia End Colostomy Prophylactic Mesh

ClinConnect Summary

This clinical trial is looking at a new way to prevent parastomal hernias, which are bulges that can occur after surgery when a stoma (an opening in the abdomen for waste removal) is created. These hernias can happen to a significant number of patients—between 30% to 50%—within the first year after surgery, leading to various problems, some of which can be serious. The trial will evaluate the effectiveness of a special three-dimensional, funnel-shaped mesh designed to reduce the chances of developing these hernias after surgery.

To participate in this study, patients should be undergoing a type of surgery called a definitive colostomy, have certain health conditions that qualify, and be able to give consent to join the trial. It's important to note that not everyone will qualify, such as those with specific types of colostomies. Participants will be monitored after their surgery to see how well this mesh works in preventing hernias, helping researchers better understand its effectiveness and potentially improve outcomes for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients undergoing a definitive colostomy confection
  • Terminal colostomy confection
  • ASA index III or inferior
  • Patients who have given legat authorization to participate in the study
  • Exclusion Criteria:
  • Lateral colostomy or a colostomy that will be removed posteriorly

About Consorci Sanitari Integral

Consorci Sanitari Integral is a prominent healthcare organization dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong commitment to collaboration and quality, the consortium integrates a network of healthcare providers, facilitating multidisciplinary approaches to clinical research. Their focus encompasses a wide range of therapeutic areas, aiming to enhance treatment outcomes and contribute to the advancement of medical science. By leveraging state-of-the-art facilities and a team of experienced professionals, Consorci Sanitari Integral is poised to make significant contributions to the evolving landscape of healthcare.

Locations

Sant Joan Despí, Barcelona, Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported