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临床试验/NCT07064694
NCT07064694已完成不适用

Hybrid Parastomal Endoscopic Repair (HyPER): Ten-Year Experience and Lessons Learned From a Single-Center Cohort of 200 Patients

Swissmed Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月1日最近更新:
适应症

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

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))

研究者

发起方
Swissmed Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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