Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

NCT ID: NCT06791642

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2025-01-01

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.

Conditions

Parastomal Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Group 1: Parietex™ Composite Mesh

Group 1: Parietex™ Composite Mesh

This group consisted of patients who had their PSH repair performed using the Parietex™ Composite Mesh, a dual-layer synthetic mesh designed to promote tissue integration while minimizing the risk of adhesions. The Parietex™ mesh is composed of a macroporous structure on one side, which facilitates tissue ingrowth, and an anti-adhesive barrier on the other side to reduce complications such as bowel adhesions or erosion. This mesh was applied using the sandwich technique, combining a keyhole configuration around the stoma with an overlay reinforcement of the abdominal wall.

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

Intervention Type: DEVICE

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.

Group 2: Synecor™ Hybrid Mesh

This group included patients who underwent PSH repair using the Synecor™ Hybrid Mesh, an advanced composite mesh that combines biologic and synthetic materials. The Synecor™ mesh integrates a bioresorbable layer for improved biocompatibility and tissue integration with a synthetic layer to enhance long-term strength and durability. It also incorporates anti-adhesive properties to minimize the risk of complications. Similar to the Parietex™ group, this mesh was used in the sandwich technique to provide dual-layer reinforcement.

Key features of this group:

• Mesh composition: Hybrid with bioresorbable and synthetic components for strength and tissue integration.
• Clinical outcomes assessed: Recurrence rates, SSIs, seromas, and mesh-related complications, including hematomas or bulging.

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale Napoli 2 Nord

OTHER

Sponsor Role: lead

Responsible Party

Francesco Pizza

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

francesco pizza, PhD

Role: STUDY_DIRECTOR

Azienda Sanitaria Locale Napoli 2 Nord

Locations

francesco Pizza

Naples, Italy, Italy

Countries

Italy

References

Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.

Reference Type: BACKGROUND

PMID: 29134456 (View on PubMed)

Other Identifiers

20252819

Identifier Type: -

Identifier Source: org_study_id