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临床试验/NCT02616718
NCT02616718已完成不适用

Incisional Hernia Progression Over Time

Bispebjerg Hospital2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Fascial defect area

研究概览

简要总结

This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect >7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia.

If surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan).

If a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.

详细描述

This is a prospective multicenter study of patients diagnosed with a medium to giant incisional hernia (transverse defect >7 cm). Patients referred to the surgical outpatient clinic are invited to participate in the study. As a standard, all patients who are examined for incisional hernia undergo CT scan according to a hernia protocol, before planning of surgical repair (baseline scan). After this CT scan, patients are seen in the out-patient clinic once again and either treated conservatively without surgery, or scheduled for elective surgical repair of the hernia.

If surgery is planned, the patients participating in the study undergo an additional CT scan in hernia protocol, within two weeks prior to surgery (follow-up scan). In case no baseline scan in hernia protocol exists, patients will undergo this scan immediately after inclusion in the study. Furthermore, patients will be asked to fill out a questionnaire on physical activity (IPAQ) and hernia-related quality of life (HerQLes) at the time of the baseline and follow-up scans. IPAQ is a well-validated questionnaire, which assesses patients' physical activity within the last 7 days. The outcome is metabolic minutes per week, a numerical value which places the responder in one of three categories: Low, moderate or high physical activity. HerQLes is a validated questionnaire assessing the hernia-related quality of life. This questionnaire has been translated into Danish using a standardized protocol. The outcome is a numerical score of 0-100, with 100 being the highest hernia-related quality of life. Currently, the time from planning of hernia repair to surgery is approximately 30 weeks. Thus, the mean time between the two CT scans should be around 28-32 weeks.

If a conservative non-surgical approach is chosen, patients can still participate in the study and will undergo an additional CT scan after 28-32 weeks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Suspected incisional hernia with a horizontal fascial defect > 7 cm

排除标准

  • Inability to read or speak Danish

研究组 & 干预措施

Ventral incisional hernia

Experimental

Repeated computed tomography scan of abdomen

干预措施: Repeated computed tomography scan of abdomen (Radiation)

结局指标

主要结局

Fascial defect area

时间窗: 28-32 weeks

Change fascial defect area from initial CT scan to follow-up CT scan

次要结局

  • Hernia sac volume(28-32 weeks)
  • Hernia-related quality of life(28-32 weeks)
  • Physical activity(28-32 weeks)

研究者

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

Kristian Kiim Jensen

MD

Bispebjerg Hospital

研究点 (2)

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