Image

Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.

Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia.

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Description

Several surgical scenarios include colon diversion as part of their management. Among them, the most frequent conditions requiring colostomy are abdominal malignancies, large bowel diverticulitis, Inflammatory Bowel Disease, bowel obstruction or perforation and postoperative complications such as anastomotic leakage. Colostomy related morbidity includes retraction, infection, prolapse, skin problems and parastomal hernia. Parastomal Hernia is a quite common late complication, with a clinical rate up to 55%, reaching 80% when assessed by Computer Tomography. Although Parastomal Hernia is often asymptomatic, significant morbidity exists, including pain, intermittent obstruction, stoma leakage, skin irritation and pouching, often reducing patients' Quality of Life. Several surgical options are available for Parastomal Hernia repair, many of them supporting the use of mesh to strengthen the fascia. However, results are often disappointing with quite high recurrence rates, rising up to 33%, even with the use of a mesh. Several studies have been published, testing effectiveness and safety of a prophylactic mesh in vertical laparotomy closure to prevent incisional hernia.

The aim of this study was to assess feasibility, potential benefits and safety of a prophylactic biosynthetic mesh placed at the time of colostomy.

Eligibility

Inclusion Criteria:

  • age > 18 years
  • endo colostomy
  • Informed consent

Exclusion Criteria:

  • age < 18 years;
  • life expectancy < 24 months (as estimated by the operating surgeon)
  • pregnancy
  • immunosuppressant therapy within 2 weeks before surgery

Study details
    Parastomal Hernia

NCT04749329

Azienda Sanitaria Locale Napoli 2 Nord

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.