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Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

NCT06791642 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2025-01-27

No results posted yet for this study

Summary

This study focuses on improving the surgical repair of parastomal hernias (PSHs), which are a common complication for patients with stomas. The investigators are examining the effectiveness of a specific technique called the "sandwich method," which uses two layers of mesh to reinforce the hernia site and reduce recurrence. The objective is to evaluate how well this method works over time, assess its impact on patient recovery and quality of life, and compare outcomes for different types of surgical materials used. This research aims to provide clearer guidance for surgeons and improve long-term results for patients undergoing PSH repair.

Conditions

  • Parastomal Hernia

Interventions

DEVICE

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

The sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field. Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh used:1. Parietex™ Composite Mesh (Medtronic, USA): A multifilament polyester mesh with an anti-adhesive collagen barrier to minimize visceral adhesions.

DEVICE

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

The sandwich technique was performed laparoscopically according to minimally invasive principles. Pneumoperitoneum was typically established using a Veress needle if the subcostal region was free from previous surgical scarring. For patients with prior extensive abdominal surgeries, a small laparotomy was performed to place the first 10-mm trocar directly under vision, ensuring safe entry into the peritoneal cavity. A 30° laparoscope was used throughout the procedure for enhanced visualization of the operative field. Trocar placement was designed to optimize access and ergonomics. The primary trocar was placed either in the periumbilical region or in the left or right flank, depending on the patient's anatomy and stoma location. Mesh use Synecor™ Hybrid Mesh (BD, USA): A macroporous mesh combining polypropylene with a bioresorbable layer that degrades over time, leaving a durable support structure to promote tissue integration.

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 2 Nord

    lead OTHER

Principal Investigators

  • francesco pizza, PhD · Azienda Sanitaria Locale Napoli 2 Nord

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-12-31
Completion
2025-01-01
FDA Device
Yes

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 NCT06791642 on ClinicalTrials.gov