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临床试验/NCT00412659
NCT00412659已完成2 期

An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus

Umeå University2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2006年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
125
试验地点
2
主要终点
time to complete wound healing

研究概览

简要总结

The trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.

详细描述

Excision in the midline and primary suture is a long proven method of treating pilonidal sinus. However it's associated with high incidence of post operative infection and recurrence. On the other hand Karydakis operation (excision lateral of the midline, transposition flap and primary suture) is just a slightly more complicated procedure but has five times less recurrences reported in case series. The purpose of the present study is to compare the surgical results and costs of the two surgical methods utilized. In addition the investigators aim to compare the quality of life at defined time points after surgery. Eligible patients are randomized to two groups of surgeons, well trained in either the midline operation or the Karydakis operation (expertise based design). The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.

Comparison: Midline excision andd primary suture compared with the Karydakis operation (excision lateral of the midline and primary suture) for pilonidal disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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 or older.
  • •Surgery is considered the best available treatment.
  • •The patient understands trial information and is capable of making a decision for informed consent after having received information.
  • •The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial.

排除标准

  • •Patient has had a pilonidal abscess during the last four weeks before the planned day of surgery
  • •Patient has had surgery (excision) for pilonidal sinus more than once before.

研究组 & 干预措施

Karydakis

Active Comparator

Karydakis operation for pilonidal sinus disease.

干预措施: Surgery for pilonidal disease, Karydakis operation (Procedure)

Midline excision

Active Comparator

Midline excision for pilonidal sinus disease.

干预措施: Surgery for pilonidal disease, midline excision (Procedure)

结局指标

主要结局

time to complete wound healing

时间窗: one year or until reoperation

次要结局

  • days spent on sick-leave(one year or until reoperation)
  • postoperative wound infection rate(one year or until reoperation)
  • health-related quality of life(one year)
  • recurrence rate(one year or until reoperation)
  • time needed returning to normal physical activity after operation(one year or until reoperation)
  • health care costs and total costs(one year)

研究者

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

Markku Haapamaki

Associate professor, MD, PhD

Umeå University

研究点 (2)

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