Giant Ventral Incisional Hernia: Characteristics of Abdominal Muscle-matrix, and Effect of Hernia Repair on Abdominal Wall Function, Respiratory Performance and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Abdominal wall strength
研究概览
简要总结
One of five patients undergoing open abdominal surgery develops an abdominal wall defect (incisional hernia) as a late complication. A fraction of these are "giant" hernia with a fascial defect beyond 10 cm. These patients are physically severely impaired, and surgical treatment is complex.
Correction of giant incisional hernias including a relatively new and minimally invasive technique, (endoscopic components separation) offers promising results. This procedure allows the abdominal muscles to be joined centrally restoring the integrity of the abdominal wall.
The treatment of patients with giant hernia is now centralized at Bispebjerg Hospital allowing for a joint study between surgeons, pulmonologists, and sports medicine researchers to define the functional and biophysical outcome from hernia repair. We hypothesize that the abdominal muscle function is significantly optimized after restoration of the abdominal wall using this technique, and that muscular function is crucial for the postoperative quality of life. Moreover, we want to assess whether this operation specifically optimizes the function and protein synthesis of the abdominal wall muscles, and exerts a beneficial effect on lung function. Finally, we will investigate if the patients with giant incisional hernia may be identified by an altered composition of their connective tissue as compared with patients who do not develop incisional hernia.
This is a prospective study of two patient groups: 1) Patients with a giant incisional hernia and 2) controls undergoing open surgery on other indications. Assessment is done pre- and perioperatively and after 1 year including muscular function, lung function, abdominal wall anatomy as provided by CT-scan, and quality of life. Specified biopsies from muscles and connective tissue are examined for muscle fiber size/type and structure by various methods, including electron microscopy and atomic force microscopy. Lung function is monitored by blood gas concentrations, Chronic Obstructive Pulmonary Disease Assessment Test questionnaire, and regular spirometry analyses. The studies are carried out by Ph.D. student Kristian Kiim Jensen, and supervised by professor in surgery Lars Nannestad Jørgensen, professor in sports medicine Michael Kjær and professor in pulmonary medicine Vibeke Backer.
详细描述
Overall project aim
The present study examines the abdominal skeletal muscle and connective tissue of patients with giant ventral incisional hernia (VIH), and to evaluate the effect of a new endoscopic components separation technique (CST) with abdominal muscle replacement upon the muscular function of the abdominal wall and quality of life in patients. The study relies on the following hypotheses:
- Collagen characteristics and organization are altered in patients with incisional hernia as compared with patients who do not develop incisional hernia.
- Reconstruction of the linea alba by endoscopic CST and medialization of the abdominal rectus muscles in patients with giant VIH leads to improvement of daily function, respiratory performance and quality of life.
- Abdominal wall reconstruction including CST with re-positioning of the rectus abdominis musculature increases the abdominal muscle mass and strength along with higher protein synthesis of the rectus muscles and a reduction of fibrotic skeletal muscle phenotype.
A total of 20 patients electively admitted for repair of a giant midline VIH, and 20 patients without hernias electively operated on for other indications are included. Exclusion criteria are pregnancy, severe heart- or lung disease, significant musculoskeletal disease, chemo- or radiotherapy within three months prior to the examination, and systemic corticosteroid medication. Oral and written informed consents are obtained from each participating patient.
Strength measurements of the m. rectus abdominis and the vastus lateralis of the quadriceps femoris muscle are done using a Good Strength muscle test system, both static and dynamic. The measurements are undertaken preoperatively and 1 year after surgery. A CT scan of the abdomen and thigh is done both 1 month before and 1 year after surgery to provide a detailed description of the hernia dimensions, the distance between the abdominal rectus muscles, and to determine the cross sectional area of the rectus abdominis and the vastus lateralis muscle. Lung function is determined by arterial blood gas, venous oxygen saturation, forced expiratory volume (FEV1), forced- and vital capacity (FVC, VC) including B2-receptor agonist reversal test, and maximum inspiratory- and expiratory pressure (MIP/MEP) preoperatively and 1 year postoperatively. Daily arterial blood gas is measured during postoperative admission. Lung function is determined at 1-month follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Giant ventral incisional hernia with fascial defect > 10 cm
- •Scheduled surgery on other indications
- •Provided informed consent
排除标准
- •Pregnancy,
- •Severe heart- or lung disease
- •Significant musculoskeletal disease
- •Chemo- or radiotherapy within three months prior to the operation
- •Systemic corticosteroid medication
结局指标
主要结局
Abdominal wall strength
时间窗: Preoperative and one year postoperative
Change in maximal abdominal wall strength measured by Good Strength system.
次要结局
- Rectus abdominis muscle phenotype(Preoperatively and one year postoperative)
- Change in respiratory function(Preoperatively, one month, and year postoperative)
- Maximal thigh strength(Preoperatively and one year postoperative)
- Connective tissue characteristics(Perioperatively)
- Rectus abdominis muscle protein synthesis activity(Preoperative and one year postoperative)
- Change in quality of life(Preoperative and one year postoperative)
研究者
Kristian Kiim Jensen
MD, PHD student
Bispebjerg Hospital