Prospective Randomized Study of the Role of Prosthetic Mesh in Preventing Parastomal Hernias in Patients With Definitive End Colostomy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Compare the incidence of parastomal hernias between groups
研究概览
简要总结
Introduction Parastomal hernia is the most common complication related to colostomies. The variability of the diagnostic criteria, the fallow up time and sometimes subclinical dimensions, detectable only with imaging, explain disparate figures cited in the literature (0-58%) (1). The generally accepted rate is around 50% (2). However, several authors consider that actually, almost all patients present parastomal hernia in the long-term fallow up (3).
Prophylactic prosthetic meshes could reduce the incidence of this complication, reinforcing since the beginning the weak peristomal area of the abdominal wall. Existing scientific evidence, although positive, is limited and does not allow to clarify some controversial issues as the type of prosthetic mesh to be used and the optimal position of the mesh in relation to the abdominal wall (4-8).
The use of laparoscopic approach in colorectal surgery is increasing and also sets technical changes to the placement of the mesh. To date, there are some technical notes (9) and two published prospective, observational studies that include patients underwent laparoscopic surgery. In the first study intraperitoneal (10) and in the second retromuscular mesh (11) is used, with encouraging short-term results, but they need more scientific support.
Study Design This is a prospective, randomized, single center, clinical study where the sample is represented by patients undergoing elective laparoscopy assisted colorectal surgery, with the creation of a permanent end colostomy. Patients who accept to participate and are suitable for inclusion to the study will be randomized into one of the two branches consecutively: Treatment A: Conventional definitive end colostomy; Treatment B: Definitive end colostomy reinforced by retromuscular mesh Ultrapro.
Aims Evaluate and compare the results obtained by placing prosthetic mesh to prevent parastomal hernia end colostomy versus realization of end colostomy by conventional technique.
Primary Objective: Compare the incidence of parastomal hernias between groups during the monitoring period.
Secondary objectives: Compare the overall and specific postoperative morbidity and mortality between groups, compare the difference in surgical time between the conventional technique and the prosthetic mesh group, compare hospital stay between the groups.
详细描述
Definition of parastomal hernia
Parastomal hernia is considered if it happens one of the following situations:
- Parastomal protrusion spontaneously or with Valsalva maneuver, evidenced by observation and palpation, exploring the patient at supine and standing position
- Protrusion of intrabdominal contents through the fascial hole, evidenced by abdominal computed tomography, in cases without clinical evidence of hernia or in obese patient whose exploration is difficult. For the description of parastomal hernias will be used the clinico-radiological classification described by Moreno et al. (12).
Ethical Issues The study is approved by the regional ethics committee. The patients candidates for the study will be informed in person by a surgeon of the team and will receive written information. Informed consent will be obtained from each patient according to the guidelines established by the ethics committee prior to randomization into the study. Patients will be free to leave the study at any time.
To ensure the optimal treatment for patients in each arm of the study, analysis will be conducted throughout the inclusion process to compare the incidence of parastomal hernias, specific morbidity and mortality specific related to the use of prosthetic mesh. If the observed differences were significant, we would stop the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with colorectal disease that require realization of definitive end colostomy
- •Laparoscopy assisted interventions
- •Interventions intended to radical treatment in case of oncologic pathology
- •Signed informed consent by the patient or representative in case of incapacity
排除标准
- •No acceptance to participate or inability to obtain signed informed consent
- •Urgent interventions
- •Palliative interventions
- •Lateral colostomies
- •American Society of Anesthesiologists (ASA) Classification IV-V
结局指标
主要结局
Compare the incidence of parastomal hernias between groups
时间窗: During the monitoring period of one year
Monitoring will be realized with clinical controls (after 15 days and 2, 6, 12 months) and with an abdominal computed tomography in the first year. The expected result is the statistically significant reduction in the incidence of parastomal hernias in patients undergoing elective laparoscopy assisted colorectal surgery with realization of end colostomy reinforced with retromuscular mesh collocation
次要结局
- Compare hospital stay between the groups(Patientes will be followed for the duration of hospital stay, an expected average of 14 days)
- Compare the overall and specific postoperative morbidity and mortality between groups(During the monitoring period of one year)
- Compare the difference in surgical time between the conventional technique and the prosthetic mesh group(During the surgery)