Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

Completed

• Conditions: Parastomal Hernia

• Registration Number: NCT06791642
• Lead Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2025-01
• Study Completion: 2025-01-01
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Specify the criteria for participating in the study in a bulleted list under each category heading ("Inclusion Criteria" and "Exclusion Criteria"). Include only one item per bullet.

Exclusion Criteria

Age below 18 years.

• Patients with recurrent parastomal hernia repairs requiring an open surgical approach.
• Evidence of active abdominal infection or sepsis at the time of surgery.
• Known allergies to mesh materials used in the study (e.g., Parietex™ or Synecor™).
• Presence of significant comorbidities making laparoscopic surgery unsafe (e.g., advanced cardiopulmonary disease).
• Pregnancy at the time of surgery.
• Inability to provide informed consent or comply with follow-up requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hernia recurrence rate	24 months	defined as clinical or radiological confirmation of a recurrent parastomal hernia.

Secondary Outcome Measures

Name	Time	Method
Mesh-Related Complications:Bowel Adhesions	until 24 months	Abnormal fibrous connections between the bowel and mesh, potentially causing pain or obstruction.
Surgical Site Infections (SSIs)	24 months	The occurrence of surgical site infections was assessed as a critical indicator of postoperative morbidity. SSIs were monitored through clinical evaluations, including signs of redness, swelling, warmth, pain, and discharge at the surgical site, and were managed according to established guidelines.
Number of Participants with Postoperative Seroma Formation:	24 months	Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Number of Participants with Postoperative Seroma Formation	1 months	Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.
Number of Participants with Postoperative Hematoma Formation	24 months	Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.
Mesh-specific complications : Mesh Migration:	until 24 month	Displacement of the mesh from its intended position.
Mesh-Related Complications:Mesh Erosion into the Stoma	until 24 months	Displacement of the mesh from its intended position.
Number of Participants with Postoperative Bowel Obstruction	until 24 months	Episodes of bowel obstruction were recorded based on patient symptoms (e.g., abdominal distension, vomiting) and confirmed using imaging studies

Trial Locations

Locations (1)

francesco Pizza; 🇮🇹 Naples, Italy