Clinical trial NCT06791642: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique:
Official title: Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique: a Multicenter Study of Clinical Outcomes, Recurrence Rates, and Quality of Life Improvements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parastomal Hernia
Keywords: stoma
hernia
Laparoscopic repair
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: hernia recurrence rate
timeFrame: 12 months
measure: hernia recurrence rate
timeFrame: 24 months
Secondary outcomes:
measure: Surgical Site Infections (SSIs)
timeFrame: 1 months
measure: Surgical Site Infections (SSIs)
timeFrame: 3 months
measure: Surgical Site Infections (SSIs)
timeFrame: 6 months
measure: Surgical Site Infections (SSIs)
timeFrame: 12 months
measure: Surgical Site Infections (SSIs)
timeFrame: 24 months
measure: Number of Participants with Postoperative Seroma Formation
timeFrame: 1 months
measure: Number of Participants with Postoperative Seroma Formation:
timeFrame: 3 months
measure: Number of Participants with Postoperative Seroma Formation:
timeFrame: 6 months
measure: Number of Participants with Postoperative Seroma Formation:
timeFrame: 12 months
measure: Number of Participants with Postoperative Seroma Formation:
timeFrame: 24 months
measure: Number of Participants with Postoperative Hematoma Formation
timeFrame: 1 months
measure: Number of Participants with Postoperative Hematoma Formation
timeFrame: 3 months
measure: Number of Participants with Postoperative Hematoma Formation
timeFrame: 6 months
measure: Number of Participants with Postoperative Hematoma Formation
timeFrame: 12 months
measure: Number of Participants with Postoperative Hematoma Formation
timeFrame: 24 months
measure: Mesh-Related Complications:Bowel Adhesions
timeFrame: until 24 months
measure: Mesh-specific complications : Mesh Migration:
timeFrame: until 24 month
measure: Mesh-Related Complications:Mesh Erosion into the Stoma
timeFrame: until 24 months
measure: Number of Participants with Postoperative Bowel Obstruction
timeFrame: until 24 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: francesco Pizza
Study officials:
affiliation: Azienda Sanitaria Locale Napoli 2 Nord
name: francesco pizza, PhD
role: STUDY_DIRECTOR
References:
citation: 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.