Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Abdominal wall strength
研究概览
简要总结
The primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of QoL before and after laparoscopic repair of small- to medium sized incisional hernia.
This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. Abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity (International Physical Activity Questionnaire) are assessed. Patients are examined before, one month after and three months after the operation. Furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective laparoscopic repair for one or more incisional hernias in the midline (at least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone), using a synthetic mesh
- •Horizontal fascial defect between 3 and 8 cm
- •Age between 25 and 75 years
- •American Association of Anesthesiologist score between I and III
- •Body mass index < 33 kg/m^2
排除标准
- •Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries
- •Existing stoma
- •Postoperative complications requiring intervention
结局指标
主要结局
Abdominal wall strength
时间窗: Change at three months from baseline examination
Abdominal wall strength measured by Goodstrength Dynamometer before, one and three months after laparoscopic incisional hernia repair.
Hernia-related quality of life
时间窗: Change at three months from baseline examination
Hernia-related quality of life (HerQLes) before, one and three months after laparoscopic incisional hernia repair.
次要结局
- Forced vital capacity(Change at three months from baseline examination)
- Forced expiratorry volume for one second (FEV1)(Change at three months from baseline examination)
- Maximal inspiratory pressure(Change at three months from baseline examination)
- Maximal expiratory pressure(Change at three months from baseline examination)
- Physical activity level(Change at three months from baseline examination)
- Pain(Change at three months from baseline examination)
- Discomfort(Change at three months from baseline examination)
研究者
Kristian Kiim Jensen
MD, PHD student
Bispebjerg Hospital