Hybrid Parastomal Endoscopic Repair (HyPER): Ten-Year Experience and Lessons Learned From a Single-Center Cohort of 200 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recurrence rate of parastomal hernia
研究概览
简要总结
Retrospective single-center study analyzing long-term outcomes of Hybrid Parastomal Endoscopic Repair (HyPER) in 200 patients with symptomatic parastomal hernias, including recurrence, complications, and quality of life.
详细描述
This is a retrospective, single-center observational study evaluating surgical management of symptomatic parastomal hernias using a standardized Hybrid Parastomal Endoscopic Repair (HyPER) technique. The HyPER method integrates laparoscopic and open approaches to enable comprehensive dissection, mesh reinforcement, and anatomical correction, including stoma relocation and soft tissue reconstruction when indicated.
All patients were classified preoperatively according to the European Hernia Society (EHS) classification. The procedure included laparoscopic adhesiolysis, open excision of the hernia sac, and laparoscopic intraperitoneal mesh fixation. A synthetic mesh (typically DynaMesh-IPST®) was used in most cases. In selected patients, a cost-effective alternative mesh was applied using a technique referred to as the "Baldachin modification," with an omental flap interposed to prevent adhesions.
The study included adult patients with symptomatic parastomal hernias who underwent elective surgery at a tertiary referral center for abdominal wall reconstruction. Exclusion criteria involved disseminated malignancy, contraindications to laparoscopy, and severely limited life expectancy. Patients were followed up in a dedicated outpatient setting with regular clinical and imaging assessments.
The aim of this study was to evaluate feasibility, safety, and the potential for broad implementation of the HyPER technique in the surgical treatment of parastomal hernias.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥ 18 years
- •Symptomatic parastomal hernia requiring surgical intervention
- •Eligibility for elective surgery
- •Preoperative classification using the European Hernia Society (EHS) system
排除标准
- 未提供
结局指标
主要结局
Recurrence rate of parastomal hernia
时间窗: Up to 10 years postoperatively (mean follow-up 61 months)
Proportion of patients with clinically or radiologically confirmed recurrence of parastomal hernia following the HyPER procedure, as assessed during routine follow-up.
次要结局
- Postoperative complications(Within 30 days postoperatively)
- Patient-reported quality of life(Baseline and last follow-up (up to 10 years))
