Laparoscopic Parastomal Hernia Repair Using the Sandwich Technique: a Multicenter Study of Clinical Outcomes, Recurrence Rates, and Quality of Life Improvements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- hernia recurrence rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
hernia recurrence rate
时间窗: 24 months
defined as clinical or radiological confirmation of a recurrent parastomal hernia.
次要结局
- Mesh-Related Complications:Bowel Adhesions(until 24 months)
- Surgical Site Infections (SSIs)(24 months)
- Number of Participants with Postoperative Seroma Formation:(24 months)
- Number of Participants with Postoperative Seroma Formation(1 months)
- Number of Participants with Postoperative Hematoma Formation(24 months)
- Mesh-specific complications : Mesh Migration:(until 24 month)
- Mesh-Related Complications:Mesh Erosion into the Stoma(until 24 months)
- Number of Participants with Postoperative Bowel Obstruction(until 24 months)
研究者
Francesco Pizza
PhD
Azienda Sanitaria Locale Napoli 2 Nord