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

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

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 Overview

• Status: Recruiting
• Conditions: Parastomal Hernia
• Intervention / Treatment: Device: Mesh Group

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesco Pizza, Md, PhD; Phone Number: 3338275449; Email: francesco_pizza@libero.it
• Study Contact Backup: Name: Francesco Pizza, Md, PhD; Phone Number: 3338275449; Email: francesco.pizza@laslnapoli2nord.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Aslnapoli2Nord
    • Contact: francesco pizza, md phd; Email: francesco.pizza@libero.it
    • Contact: dario d'antonio, md; Email: dario.dantonio@libero.it
  • Naples, Italy, 80131
    • Not yet recruiting
    • francesco Pizza
    • Contact: francesco pizza, md phd; Email: francesco_pizza@libero.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; no mesh was used for end colostomy fashions
Experimental: Mesh Group; Mesh of Bio A was used for end colostomy fashions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	3 months
Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	6 months
Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	12 months
Rate of Parastomal Hernia at clinical control.	Detect of paratoia hernia	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	3 months follow-up
Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	6 months follow-up
Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	12 months follow-up
Rate of Parastomal Hernia at tomography observation.	detect of parastomal hernia	24 months follow-up

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord
• Investigators: Principal Investigator: Francesco Pizza, Md, PhD, Azienda Sanitaria Locale Napoli 2 Nord

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 7, 2021
• First Submitted That Met QC Criteria: February 7, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: 212128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No