Ventral Hernia Improvement of Treatment and Life
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in quality of life after ventral hernia repair for pateints with incisional hernia
研究概览
简要总结
The goal of this clinical trial called the VITAL study is to learn if surgery has a positive impact on the quality of life in patients with incisional or parastomal hernia. The main questions it aims to answer are:
Does surgery alleviate patients from their initial problem? Does new discomfort arise after surgery? Do the symptoms worsen, and does quality of life deteriorate in patients who are not offered surgery? The project will also look at time to surgery and postoperative complications. Researchers will send questionnaires to the patients to answer.
Participants will:
Answer the baseline questionnaire. Answer the follow-up questionnaires at 1 month, 3 months, 6 months, 1 year, and 3 years after surgery or after the baseline questionnaire has been completed for those patients being managed conservatively with observation
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
- 否
入选标准
- •>18 years
- •Incisional hernia or parastomal hernia
排除标准
- •Can't understand or read Danish
结局指标
主要结局
Change in quality of life after ventral hernia repair for pateints with incisional hernia
时间窗: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Quality of life in patient with incisional hernia
时间窗: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Quality of life in patients with parastomal hernia
时间窗: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
Changes in quality of life after ventral hernia repair in patients with parastomal hernia
时间窗: From enrollment to the end of follow-up at 36 months.
The patients will receive a questionnaire at baseline and at 1, 3, 6, 12, and 36 months of follow-up. The project will use the Abdominal Hernia-Q. It features both a pre- and postoperative form, including a total of 24 items with responses scored on a 4-point Likert scale. Patient responses will be averaged, producing a possible score range of 0 to 4.
次要结局
- Time to surgery(From enrollment to the end of follow-up at 36 months.)
- Postoperative complications(From enrolment to the end of follow-up at 36 months)
- Risk of emergency surgery during the waiting time(From enrollment to the end of follow-up at 36 months)
研究者
Line Marker
Principal Investigator
Zealand University Hospital