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

Not Applicable

Recruiting

• Conditions: Parastomal Hernia
• Interventions: Device: Mesh Group

• Registration Number: NCT04749329
• Lead Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-07
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-11
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Study Start: 2024-08-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesh Group	Mesh Group	Mesh of Bio A was used for end colostomy fashions

Primary Outcome Measures

Name	Time	Method
Rate of Parastomal Hernia at clinical control.	24 months	Detect of paratoia hernia

Secondary Outcome Measures

Name	Time	Method
Number of patients affected by Superficial surgical site infections	Within 30 days postoperatively	Superficial infections according to Clavien-Dindo criteria
Number of patients affected by Deep surgical site infections	Within 30 days postoperatively	Deep surgical site infections according to Clavien-Dindo criteria
Rate of Parastomal Hernia at tomography observation.	24 months follow-up	detect of parastomal hernia

Trial Locations

Locations (2)

Aslnapoli2Nord; 🇮🇹 Naples, Italy

francesco Pizza; 🇮🇹 Naples, Italy