Safety and Efficacy of Prophylactic Resorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Field: Protocol for a Multicenter Randomized Double Blind Prospected Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Rate of Incisional Hernia at Clinical examination
研究概览
简要总结
The aim of the present study is to analyse the feasibility, safety and IH rate using a prophylactic sublay biosynthetic BIO-A (GORE) mesh in order to prevent incisional hernia following midline laparotomy in clean-contaminated and contaminated wounds. The study was designed as a double-blind randomized controlled trial comparing the running suture alone to the running suture reinforced with biosynthetic mesh (BIOA) in sub lay position.
详细描述
Incisional Hernia (IH) is one of the most frequent postoperative complications in abdominal surgery causing significant morbidity and even mortality. The risk of developing an IH following primary elective midline laparotomy is reported to be between 5 and 20 percent. Risk factors for developing IH are both patient and surgery related. Patient factors include diabetes, smoking, obesity, chronic corticosteroids use and connective tissue disorders, comprised the presence of an Abdominal Aortic Aneurysm (AAA). Surgery related factors include type of laparotomy, type of surgery, wounds classification, suture material used to close the laparotomy and the suture length to wound length ratio (SL/WL).
In patients carrying AAA and/or obesity and/or contaminated wounds, incidence rises to 39% (6,7). Besides the negative impact of incisional hernia regarding the patients' quality of life, the direct costs of hernia repair and indirect cost of IH (sick leave) are an important burden for the health care system.
Several groups investigated the role of prophylactic mesh placement in the prevention of IH occurrence. A positive conclusion was reached by two systemic reviews. On the other side, surgeons are mostly reluctant to implant permanent material in patients undergoing a contaminated ventral hernia repair for the increased risk of postoperative infections, bowel adhesions, mesh extrusion and/or erosion, fistula formation, seroma development and pain.
Recently, a retrospective study by Carbonell et al. investigated the feasibility and outcomes of open ventral hernia repairs performed with a polypropylene mesh in the retro-rectus position in clean-contaminated and contaminated fields, reporting a 30-day surgical site infection rate of 7.1 and 19.0% respectively. The most appropriate mesh for hernia repair in clean-contaminated and contaminated fields is not as clear .
Some other authors proposed the implant of Biological Meshes (BM) in contaminated and dirty wounds, but their high costs limited their use. Moreover, data about long-term durability of biologic grafts used in case of complex abdominal wall reconstruction are not clearly defined. The so-called biosynthetic meshes (BSM) may, actually, offer advantages when challenging with bacterial colonization during complex abdominal wall reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •age > 18 years
- •Clean-contaminated, contaminated wounds • midline laparotomy >10 cm
- •Informed consent
排除标准
- •age < 18 years;
- •life expectancy < 24 months (as estimated by the operating surgeon), - • pregnancy
- •immunosuppressant therapy within 2 weeks before surgery
- •clean and dirty wounds
- •wound length<10 cm.
结局指标
主要结局
Rate of Incisional Hernia at Clinical examination
时间窗: 24 months
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar
Rate of Incisional Hernia at Ultrasound examination
时间窗: 24 months
Ultrasound imaging is performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia are registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia are a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia is diagnosed if clinical criteria and/or ultrasound criteria are fulfilled.
次要结局
- Number of patients affected by Deep surgical site infections(Within 30 days postoperatively)
- Number of patients affected by Superficial surgical site infections(Within 30 days postoperatively)
研究者
Francesco Pizza
Head of Bariatric Unit
Azienda Sanitaria Locale Napoli 2 Nord