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

NCT04749329 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-10-26

No results posted yet for this study

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.

Conditions

  • Parastomal Hernia

Interventions

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.

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Principal Investigators

  • Francesco Pizza, Md, PhD · Azienda Sanitaria Locale Napoli 2 Nord

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04749329 on ClinicalTrials.gov