Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

NCT06791642 | Completed DMC FDA Device

• 1 other identifier: 20252819
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Parastomal Hernia

Keywords

stoma; hernia; Laparoscopic repair

Outcome Measures

Primary Outcomes (2)

• hernia recurrence rate

  defined as clinical or radiological confirmation of a recurrent parastomal hernia.

  12 months

• hernia recurrence rate

  defined as clinical or radiological confirmation of a recurrent parastomal hernia.

  24 months

Secondary Outcomes (19)

• Surgical Site Infections (SSIs)

  1 months

• Surgical Site Infections (SSIs)

  3 months

• Surgical Site Infections (SSIs)

  6 months

• Surgical Site Infections (SSIs)

  12 months

• Surgical Site Infections (SSIs)

  24 months

Study Arms (2)

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.

Device: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

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.

Device: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique

Interventions

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique 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 1: Parietex™ Composite Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients with a diagnosed parastomal hernia who are referred for surgical repair at participating hospitals. These patients are representative of individuals commonly managed in general and colorectal surgery practices, and they will be selected from both inpatient and outpatient settings.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

francesco Pizza

Naples, Italy, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 29134456 BACKGROUND

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• francesco pizza, PhD

  Azienda Sanitaria Locale Napoli 2 Nord

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

IT (1)