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临床试验/NCT01280370
NCT01280370已完成不适用

Prospective Evaluation of Laparoscopic and Open Hernia Repair: a Multicenter Cohort Study

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 371 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
371
试验地点
1
主要终点
recurrence rate

研究概览

简要总结

Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.

With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.

Hypothesis:

Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to open incisional hernia repair.

详细描述

Background

Incisional hernia is a common long-term complication following abdominal surgery and is estimated to occur in 11-23% 1-3. Incisional hernia can be repaired by an open or by a laparoscopic approach. For incisional hernia prosthetic meshes are nowadays implanted for virtually all open and laparoscopic procedures.

The use of laparoscopy for the treatment of incisional hernia was first reported in 1993 by LeBlanc and Booth 4. Short term follow-up studies show that laparoscopic surgery is associated with decreased postoperative pain, reduced risks of surgical site infections due to minimal tissue dissection, a shorter length of hospital stay and a shorter overall recovery period 5-9.

Important long- term outcome parameters are recurrence rate and chronic pain 10,11. Recurrence after incisional hernia repair varies widely and ranges from 1% to 35% 1,3. Morbid obesity, a previous failed open repair, large defect size and postoperative complications are associated with an increased risk for recurrence 12. Heterogeneity of hernia size and follow-up further complicate comparison of the recurrence rate between different techniques. On average, 74% of recurrences occur within the first 3 years after initial repair 13. Series with an acceptable follow-up of at least 24 months report a recurrence rate in open and laparoscopic repair of approximately 10% 1. Currently, no well designed prospective study is available comparing the incidence of recurrence between open and laparoscopic incisional hernia repair.

Such variability of patients characteristics, surgical techniques and surgical skills are likely to confound a prospective randomized trial. Consequently, a cohort study is performed allowing each surgeon to perform the technique he is most familiar with.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients over 18 years old
  • Written informed consent
  • Primary or recurrent incisional hernia
  • Exclusion Criteria
  • Systemic or severe local infections
  • Emergency procedures

排除标准

  • 未提供

结局指标

主要结局

recurrence rate

时间窗: 36 months

次要结局

  • cosmetic results(36 months)
  • surgical site infections(36 months)
  • length of hospital stay(3 months)
  • chronic pain(36 months)
  • morbidity(3 months)
  • rigidity of the abdominal wall(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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