A Prospective, Randomized, Parallel-Controlled Study Comparing Laparoscopic/Robotic Stoma Reduced-Port Fusion Surgery with Traditional Surgery in Patients with Temporary Ileostomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Overall complication rate of stoma
研究概览
简要总结
The traditional positioning and surgical methods for temporary ileostomy no longer meet the requirements of minimally invasive surgery: (1) Conventional stoma positioning often leads to the trocar incision being too close to the stoma site, increasing the risk of baseplate leakage and skin infection. (2) Since stoma positioning is required to be within the rectus abdominis, the proximity between the stoma and auxiliary incision can heighten difficulties in stoma bag attachment and raises the risk of fecal leakage. (3) Stoma retraction surgery within the rectus abdominis is more traumatic and complex. We introduce for the first time a modified stoma positioning and surgical method, termed Reduced-Port Fusion Surgery. This technique includes preoperative trocar/stoma fusion positioning and intraoperative trocar/stoma fusion surgery. The procedure is based on the 3R principles: Reposition - the stoma is repositioned within the Joint Trocar/Stoma Zone, allowing for more lateral placement to meet surgical needs without being confined to the rectus abdominis. Reduce Port - the same fusion point is used for both trocar insertion and stoma creation, enabling dual use of one site. Recognize - surgeons participate in stoma positioning, recognize the positioning, and follow the procedure. This prospective, randomized, parallel-controlled clinical study aims to evaluate whether Reduced-Port Fusion Surgery can reduce stoma-related complications, postoperative pain, improve quality of life, and facilitate stoma retraction surgery compared to traditional methods. A total of 80 participants will be randomly assigned in a 1:1 ratio. The experimental group will undergo Reduced-Port Fusion Surgery while the control group will receive traditional surgery.
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
- None
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
- •After preoperative evaluation, patients scheduled for laparoscopic/robotic colorectal surgery (rectum, sigmoid colon, left colon) who are planned to undergo prophylactic ileostomy.
- •No serious systemic infection or immunosuppression.
- •Over 18 years of age.
- •Eastern Cooperative Oncology Group Performance Status: 0-1
- •The expected survival time > 6 months.
- •The subjects voluntarily participate and sign the informed consent
排除标准
- •Any skin infectious diseases in the abdominal wall.
- •Use hormones and immunosuppressive drugs within 1 month before surgery.
- •The time between operation and the last chemotherapy was less than 1 month.
- •Any previous ostomy surgery.
- •Any serious active infection or uncontrollable infection that requires systematic treatment.
- •A clear history of neurological or psychiatric disorders.
- •Subjects may not be able to complete the study for other reasons.
结局指标
主要结局
Overall complication rate of stoma
时间窗: 7, 30, and 90 days after surgery
Observe and assess for stoma complications
次要结局
- DET(Discoloration,Erosion and Tissue overgrowth) score(7, 30, and 90 days after surgery)
- Stomal skin infection rate(7, 30, and 90 days after surgery)
- Parastostomy trocar incision infection rate(7, 30, and 90 days after surgery)
- Parastomal hernia rate(7, 30, and 90 days after surgery)
- Stoma Pain Score(7, 30, and 90 days after surgery)
- Quality of life scale score(30 and 90 days after surgery)
研究者
Tingyu Wu
Principal Investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
