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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infections (SSIs) | 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. | 1 months |
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Inclusion Criteria:
Exclusion Criteria:
Age below 18 years.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| francesco pizza, PhD | Azienda Sanitaria Locale Napoli 2 Nord | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| francesco Pizza | Naples | Italy | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29134456 | Result | 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. |
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Explanation for Not Sharing Individual Participant Data (IPD)
Individual participant data (IPD) will not be shared due to the following considerations:
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 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. |
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| Surgical Site Infections (SSIs) |
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 months |
| Surgical Site Infections (SSIs) | 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 months |
| Surgical Site Infections (SSIs) | 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. | 12 months |
| Surgical Site Infections (SSIs) | 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. | 24 months |
| Number of Participants with Postoperative Seroma Formation | Accumulation of fluid at the surgical site, confirmed through physical examination or imaging. | 1 months |
| Number of Participants with Postoperative Seroma Formation: | Accumulation of fluid at the surgical site, confirmed through physical examination or imaging. | 3 months |
| Number of Participants with Postoperative Seroma Formation: | Accumulation of fluid at the surgical site, confirmed through physical examination or imaging. | 6 months |
| Number of Participants with Postoperative Seroma Formation: | Accumulation of fluid at the surgical site, confirmed through physical examination or imaging. | 12 months |
| Number of Participants with Postoperative Seroma Formation: | Accumulation of fluid at the surgical site, confirmed through physical examination or imaging. | 24 months |
| Number of Participants with Postoperative Hematoma Formation | Localized blood collection near the surgical site, evaluated clinically or with imaging as needed. | 1 months |
| Number of Participants with Postoperative Hematoma Formation | Localized blood collection near the surgical site, evaluated clinically or with imaging as needed. | 3 months |
| Number of Participants with Postoperative Hematoma Formation | Localized blood collection near the surgical site, evaluated clinically or with imaging as needed. | 6 months |
| Number of Participants with Postoperative Hematoma Formation | Localized blood collection near the surgical site, evaluated clinically or with imaging as needed. | 12 months |
| Number of Participants with Postoperative Hematoma Formation | Localized blood collection near the surgical site, evaluated clinically or with imaging as needed. | 24 months |
| Mesh-Related Complications:Bowel Adhesions | Abnormal fibrous connections between the bowel and mesh, potentially causing pain or obstruction. | until 24 months |
| Mesh-specific complications : Mesh Migration: | Displacement of the mesh from its intended position. | until 24 month |
| Mesh-Related Complications:Mesh Erosion into the Stoma | Displacement of the mesh from its intended position. | until 24 months |
| Number of Participants with Postoperative Bowel Obstruction | Episodes of bowel obstruction were recorded based on patient symptoms (e.g., abdominal distension, vomiting) and confirmed using imaging studies | until 24 months |