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Completed

NCT Number: NCT06791642

Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

francesco Pizza

Naples, Italy, 80131

About this study

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:

  • Effectiveness: Measuring recurrence rates over time, particularly for patients with larger hernias or recurrent hernias.
  • Safety: Assessing complications such as infections, seromas (fluid accumulation), or mesh-related issues.
  • Quality of Life (QoL): Using patient-reported surveys to evaluate how the repair impacts physical comfort, stoma care, body image, and social activities.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. hernia recurrence rate

    Time frame: 12 months

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

  2. hernia recurrence rate

    Time frame: 24 months

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

Secondary outcomes

  1. Surgical Site Infections (SSIs)

    Time frame: 1 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.

  2. Surgical Site Infections (SSIs)

    Time frame: 3 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.

  3. Surgical Site Infections (SSIs)

    Time frame: 6 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.

  4. Surgical Site Infections (SSIs)

    Time frame: 12 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.

  5. Surgical Site Infections (SSIs)

    Time frame: 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.

  6. Number of Participants with Postoperative Seroma Formation

    Time frame: 1 months

    Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.

  7. Number of Participants with Postoperative Seroma Formation:

    Time frame: 3 months

    Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.

  8. Number of Participants with Postoperative Seroma Formation:

    Time frame: 6 months

    Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.

  9. Number of Participants with Postoperative Seroma Formation:

    Time frame: 12 months

    Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.

  10. Number of Participants with Postoperative Seroma Formation:

    Time frame: 24 months

    Accumulation of fluid at the surgical site, confirmed through physical examination or imaging.

  11. Number of Participants with Postoperative Hematoma Formation

    Time frame: 1 months

    Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.

  12. Number of Participants with Postoperative Hematoma Formation

    Time frame: 3 months

    Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.

  13. Number of Participants with Postoperative Hematoma Formation

    Time frame: 6 months

    Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.

  14. Number of Participants with Postoperative Hematoma Formation

    Time frame: 12 months

    Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.

  15. Number of Participants with Postoperative Hematoma Formation

    Time frame: 24 months

    Localized blood collection near the surgical site, evaluated clinically or with imaging as needed.

  16. Mesh-Related Complications:Bowel Adhesions

    Time frame: until 24 months

    Abnormal fibrous connections between the bowel and mesh, potentially causing pain or obstruction.

  17. Mesh-specific complications : Mesh Migration:

    Time frame: until 24 month

    Displacement of the mesh from its intended position.

  18. Mesh-Related Complications:Mesh Erosion into the Stoma

    Time frame: until 24 months

    Displacement of the mesh from its intended position.

  19. Number of Participants with Postoperative Bowel Obstruction

    Time frame: until 24 months

    Episodes of bowel obstruction were recorded based on patient symptoms (e.g., abdominal distension, vomiting) and confirmed using imaging studies

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 2 Nord

Other

Registry information

Official study title

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

Acronym: APOLLO

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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