Randomised Trial Evaluating the Effect of Postoperative Girdle Following Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pulmonary function
研究概览
简要总结
There is a considerable lack of knowledge in everyday surgical practice concerning treatment with a corset after laparotomy, in surgery for incisional hernia or as conservative treatment.
The aims are to elucidate effects of corset treatment on patient experience and pain, physiology and abdominal wall strength.
Effects of corset treatment after laparotomy will be studied in a randomised trial with the hypothesis that postoperative corset-use improves respiratory physiology and reduce pain. The primary end-point is PeakCoughFlow change, secondary end-points are vital capacity, residual volumes and patient perception as measured by the ventral hernia pain questionnaire (VHPQ) developed by our group. This study is powered for 50 patients.
Conclusions from the study are of such a nature that they can be immediately transferred to clinical practice.
详细描述
Presently, there is a significant lack of knowledge in everyday surgical practice concerning treatment for incisional hernias and treatment with a corset before and after surgery or as a means of conservative treatment. For many years, corsets have been used in surgical departments without evidence to support this practice.
Corsets are expensive and require good patient compliance. Some arguments for the use of corsets are reduced pain and tension in the abdominal wall and prevention of the development and recurrence of incisional hernias, as well as their use as a truss in cases where conservative treatment is decided on.
The aim of this project is thus to ameliorate the lack of knowledge surrounding corset use.
More specifically, the aims of the project are to clarify the effects of corset use on
- Physiological parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •The inclusion in the study is done to reflect the normal population on a colorectal surgery ward.
- •Inclusion Criteria:
- •Patients undergoing laparotomy with a midline incision more than 12 cm
- •Over 18 years of age
- •Planned time at ward less than 10 days
- •Not on oxygen treatment at home
排除标准
- •are minimized but made to avoid obvious confounding
- •Exclusion Criteria:
- •Not possible to understand instructions
- •Children (<18 years of age)
- •Not involved in other studies during the project
研究组 & 干预措施
No girdle postoperative
patients undergoing major abdominal surgery will get NO individualized girdle. Functional outcomes as pulmonary function and pain are measured daily. Participants will be followed for the duration of 5 days or the duration of hospital stay, if shorter than 5 days.
干预措施: No girdle (Procedure)
Girdle postoperative
patients undergoing major abdominal surgery will get an individualized girdle. Functional outcomes as pulmonary function and pain are measured daily. Participants will be followed for the duration of 5 days or the duration of hospital stay, if shorter than 5 days.
干预措施: Girdle (Procedure)
结局指标
主要结局
pulmonary function
时间窗: 20120630
Participans will be followed for the duration of 5 days or the duration of hospital stay, if shorter than 5 days. Spirometry will be assessed the day before surgery and therafter the day after surgery and every day after the end of the study.
次要结局
- postoperative pain(20120630)
研究者
Karin Strigard
ass. professor
Karolinska Institutet