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

Parastomal Hernia Clinical Trial

Official title:

Randomized Double-blind Study on the Use of Resorbable Prosthetic Mesh "Ante Rectus" as a Prevention of Parastomal Hernia in Patients Undergoing Terminal Colostomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749329
• Other study ID #: 212128
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Azienda Sanitaria Locale Napoli 2 Nord
• Contact: Francesco Pizza, Md, PhD
• Phone: 3338275449
• Email: francesco_pizza[@]libero.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Device:
• Mesh Group
All MG patients underwent the procedure with ante rectus positioned prophylactic mesh according to the following standardized technique. A BIO-A circular-shaped mesh measuring 8X10 cm in diameter is prepared with an internal 2 cm hole to let the bowel pass. An at least 8x8 cm space is created between the anterior rectus sheath and the rectus abdominis muscle and, then, the mesh is positioned. The bowel is passed through the rectus muscle via the circular incision in the middle of the mesh. Single absorbable monofilament sutures anchored the mesh laterally in the ante rectus pocket, while medially the mesh is fixed with four stitches to the colon and to both the anterior rectal sheet. The stoma is attached to the skin similarly to CG patients.

Locations

Country	Name	City	State
Italy	Aslnapoli2Nord	Naples
Italy	francesco Pizza	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Napoli 2 Nord

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	3 months
Primary	Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	6 months
Primary	Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	12 months
Primary	Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	24 months
Secondary	Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	3 months follow-up
Secondary	Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	6 months follow-up
Secondary	Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	12 months follow-up
Secondary	Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	24 months follow-up
Secondary	Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively