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临床试验/NCT01635868
NCT01635868已完成不适用

Long Term Recurrence and Chronic Pain After Repair for Small Umbilical or Epigastric Hernias. A Regional Cohort Study.

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 1,313 人开始时间: 2012年12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
1,313
试验地点
1
主要终点
recurrence (clinical or reoperation for recurrence)

研究概览

简要总结

Background Mesh repair reduces the risk of reoperation for recurrence in patients with small umbilical and epigastric hernias compared with sutured repair. However, reoperation for recurrence underestimates total recurrence (reoperation or clinical) and mesh reinforcement may induce chronic pain. This study investigated the cumulated risk of recurrence after open mesh and sutured repair in small (≤2 cm) umbilical and epigastric hernias. Possible risk factors were evaluated for chronic pain and recurrence.

Methods A cohort study with questionnaire-follow-up was conducted. Patients with primary, elective, open mesh or sutured repair for a small umbilical or epigastric hernia (≤2 cm) were included. Follow-up was performed by a validated questionnaire regarding suspicion of recurrence and chronic pain (moderate or severe). Suspected recurrence qualified for clinical examination. Recurrence was defined as reoperation for recurrence or clinical recurrence. Risk factors for recurrence and chronic pain were investigated by multivariate analyses.

Results

1 313 patients completed the questionnaire and/or clinical follow-up (83 % response rate) and follow-up time was median 40 months (range 0-66 months). The total cumulated recurrence rate 55 months after primary repair was 10 % for mesh repair and 21 % for sutured repair (P=0.001). The incidence of chronic pain was 6 % after mesh repair and 5 % after sutured repair (P = 0.711). Recurrence was the only independent risk factor for chronic pain (P<0.001).

Conclusion Mesh repair halved the long-term risk of recurrence after repair for small umbilical and epigastric hernias without increased risk of chronic pain.

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

  • elective open mesh or sutured repair of small umbilical or epigastric hernia repairs

排除标准

  • acute operation
  • operation outside region of Zealand
  • laparoscopic repair

结局指标

主要结局

recurrence (clinical or reoperation for recurrence)

时间窗: 3 years

follow-up time will be from 3-5 years

次要结局

  • chronic pain(3-5 years after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Willaume Christoffersen

MD

Hvidovre University Hospital

研究点 (1)

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