Prophylactic Onlay Mesh Reinforcement vs Anatomical Closure in Stoma Reversal: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incisional (stoma-site) hernia rate
研究概览
简要总结
In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (SSIH),incidence of surgical site infection , post-operative Pain and Hospital stay
详细描述
Intestinal stomas are used to divert intestinal content as a treatment option. Faecal flow is diverted from the site of the pathology by bringing the end or a loop of bowel through the anterior abdominal wall; any segments of the colon can be used, as well as the distal part of the ileum. A stoma may be temporary or permanent according to the condition. Temporary stomas are usually followed by elective stoma closure 6-8 weeks after. Though considered a relative safe procedure, studies reported high morbidity rates following stoma closure with different complications.
Incisional hernia following stoma closure occurs in up to 30% of patients. Incisional hernia affects quality of life, in regards to pain, physical function, ability to work, and cosmoses. Other serious complications due to bowel obstruction with incarceration or strangulation can occur which may necessitate reoperation. Mesh-reinforced stoma closure shown to decrease the incidence of surgical site incisional hernia (SSIH) with low complications risk. Though there is a debate about its efficacy due to lake of data ,and doubt to use a mesh in contaminated wounds due to fear of wounds complications which may necessitate mesh extraction or longer hospital stay make it hard for many surgeons to use Mesh-reinforced stoma closure.
In the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing (SSIH),incidence of surgical site infection ,post-operative Pain and Hospital stay
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
盲法说明
This is an open-label study. Neither the participants, the treating surgeons, nor the outcome assessors are blinded to the assigned intervention due to the surgical nature of the procedures.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are fit for aesthesia.
- •Patients with temporary double barrelled and simple loop ostomy
- •Patients older than 16 years old
- •Exclusion criteria:
- •Patients with end ostomy
- •Infected stomas
排除标准
- 未提供
结局指标
主要结局
Incisional (stoma-site) hernia rate
时间窗: Up to 12 months postoperatively
Proportion of participants developing an incisional hernia at the stoma site, confirmed by physical examination or imaging (ultrasound/CT).
次要结局
- Surgical site infection rate(Within 30 days postoperatively)
- post-operative Pain(Daily for the first 7 postoperative days)
- Length of hospital stay(through study completion, an average of 2 years)
- Postoperative complications(Within 30 days postoperatively)
- Operative time(Intraoperative (from skin incision to skin closure))
- Intraoperative blood loss(through study completion, an average of 2 years)
研究者
Mahmoud Abdelwahed Abdeljaber
Principal investigator
Assiut University