Abdominal Midline Incisional Hernia Repair and Functional Outcome: Randomized Controlled Trial to Compare Open and Laparoscopic Surgical
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Does Laparoscopic repair generate better functional outcome compared to the open mesh repair. Functional outcome includes pain, quality of life, body image and cosmetic measurements.
研究概览
简要总结
Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence rates under 10%. Recurrence rate alone is not the main quality criterion for incisional hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Discomfort, pain, diminished quality of life and body image alteration influences functional well being. No baseline information exists in any of these fields treating pre- or post-operative phases in patients with incisional hernia. Respiratory functions and medico-economic evaluation are other rarely investigated fields that we consider in our trial. The objective of this study is to analyse the functional outcome status of patients after laparoscopic incisional hernia repair compared to open repair.
Methods: A randomized controlled non-blinded clinical trial is designed to compare laparoscopic incisional hernia mesh repair with open repair on post operative pain, health related quality of life outcomes, body image and cosmetic measurements, respiratory functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 18 years, with reducible incisional hernia who are candidates for elective surgery and medically fit for general anesthesia.30 patients will be enrolled for each group. Follow-up will take place at 10th, 30th days as well as 3 12 and 24 post operative months by questionnaires and by clinical exam by independent expert. An overall cost-analysis will be realized. Patient enrollment in the study will start in April 2008 and estimated to end in september 2009.
详细描述
Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Discomfort, pain, body image alteration and diminished quality of life influences functional well being. Alteration in pulmonary function, risk of visceral incarceration or cutaneous complications are potential medical complications. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Recurrence rate with prosthetic repair in published series vary from 4% to 29%. Different techniques for mesh placement and variety of mesh and fixation material explains this wide range of recurrence rate nevertheless, large series with standardized techniques report less than 4% of recurrence rates.
Laparoscopic repair for incisional hernia is first published in 1993. Following reported large personal series in recent years and evolution of adapted materiel, this technique gained popularity.
The main difference between open and laparoscopic techniques is the reconstruction of the abdominal wall. In all open techniques, abdominal wall is reconstructed (hernia edges brought together) with reinforcement of the abdominal wall by a mesh inserted onlay, sublay or inlay. In laparoscopic repair, the fascial defect is left in-situ but reinforced with a mesh, overlapping largely the edges of hernia.
Advocated advantages of laparoscopy are: less abdominal wall dissection (less surgical complications), tension-free mesh repair (no suturing), less postoperative pain, less respiratory complications, shorter hospital stay, faster return to professional activity. Disadvantages attributed to laparoscopic repair are the steep learning curve, high material cost, longer operation times and rare but serious complications.
Large series and meta analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Most of the trials are focused on recurrence, complication rate, hospital stay and sick leave. Only recently, quality of life and pain started to be evaluated. No valuable data exists on chronic pain or persistent neuralgia, body image, cosmesis or neuroticism neither after open nor the laparoscopic repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 18 years or older
- •Diagnosis of reducible incisional hernias up to 200 cm²
- •Medically fit for general anesthesia
- •Comprehension and use of French language
- •Installed in the geographical region without foreseeable move for two years
排除标准
- •Incarcerated hernia
- •Ongoing chronic pain syndrome, other than hernia origin
- •Coagulation disorders, prophylactic or therapeutic anticoagulation, unable to stop platelet antiaggregation therapy 10 days before surgery
- •American Society of Anesthesiology Class 4 and 5 patients
- •Emergency surgery, peritonitis, bowel obstruction, strangulation, perforation
- •Mentally ill patients
- •Presence of local or systemic infection
- •Life expectancy < 2 years
- •Any cognitive impairment (Psychiatric disorder, Alzheimer's disease etc.)
- •Morbid obesity (BMI over 40)
结局指标
主要结局
Does Laparoscopic repair generate better functional outcome compared to the open mesh repair. Functional outcome includes pain, quality of life, body image and cosmetic measurements.
时间窗: Preoperative, 10, 30, 90, 365 and 730 postoperative days
次要结局
- Respiratory function(Preoperative, 10, 90 and 365 postoperative days)
- Influence of neuroticism on overall outcome(Preoperative, 10, 30, 90, 365 and 730 postoperative days)
- Postoperative surgical and medical complications(Preoperative, 10, 30, 90, 365 and 730 postoperative days)
- Overall cost analysis(Two years after the operation)
- Recurrence rate(Two years after the operation)