NCT06791642

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique: A Multicenter Study of Clinical Outcomes, Recurrence Rates, and Quality of Life Improvements

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Description: Improving Surgical Outcomes for Parastomal Hernia Repair Parastomal hernias (PSHs) are a common and challenging complication that occurs in patients with stomas-surgically created openings in the abdomen used to divert waste. These hernias can cause discomfort, limit daily activities, and require surgical intervention to repair. Despite advancements in surgical techniques, PSH repair remains a complex issue, with high recurrence rates and varying outcomes. This study investigates the effectiveness of a specific surgical approach called the "sandwich technique" for PSH repair. This method uses two layers of mesh to reinforce the abdominal wall and provide extra support around the stoma, aiming to reduce the likelihood of hernia recurrence while maintaining the function of the stoma. The first layer of mesh is placed directly around the stoma in a "keyhole" fashion, and the second layer reinforces the surrounding abdominal wall in a broader "overlay" configuration. The research evaluates multiple aspects of this technique: 1. Effectiveness: Measuring recurrence rates over time, particularly for patients with larger hernias or recurrent hernias. 2. Safety: Assessing complications such as infections, seromas (fluid accumulation), or mesh-related issues. 3. Quality of Life (QoL): Using patient-reported surveys to evaluate how the repair impacts physical comfort, stoma care, body image, and social activities. 4. Comparison of Materials: Analyzing outcomes for two commonly used mesh types-Parietex™ Composite Mesh and Synecor™ Hybrid Mesh-to determine if material selection affects long-term results. The study incorporates the European Hernia Society (EHS) classification system to categorize hernia types based on size and complexity. This allows for a tailored approach to treatment and helps identify which patients may benefit most from specific surgical strategies. While the sandwich technique has shown promise in reducing recurrence rates and enhancing recovery, this research seeks to provide stronger evidence to guide surgeons in selecting the best techniques and materials for PSH repair. By focusing on patient-centered outcomes and refining surgical methods, the study aims to improve long-term results and overall quality of life for individuals living with stomas.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2022-12-31
• Completion: 2025-01-01
• First posted: 2025-01-24
• Last updated: 2025-01-27

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study