NCT07335731招募中不适用
Study on the Safety and Efficacy of Domestic Single-Port Robot-Assisted Metabolic Bariatric Surgery.
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of weight loss
研究概览
简要总结
This study aims to obtain short-term clinical results on the safety and efficacy of single-port robot-assisted metabolic weight loss surgery, and to provide further evidence for the clinical promotion of single-port robot systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •①Overweight or obese patients who meet the criteria for metabolic weight loss surgery, with a BMI ≥ 27.5 kg/m2; ② Patients who understand the purpose of the trial, voluntarily participate in the trial, and sign an informed consent form.
排除标准
- •① Patients who cannot tolerate general anesthesia, such as those with severe heart, lung, or liver dysfunction; ② Patients with severe coagulation disorders; ③ Pregnant patients; ④ Patients with concurrent tumors; ⑤ Patients with extensive and severe abdominal adhesions that prevent the establishment of pneumoperitoneum; ⑥ A BMI > 50 kg/m² is a relative contraindication; ⑦ Patients deemed unsuitable for participation in this trial by any other investigator.
研究组 & 干预措施
Robotic surgical treatment group
Experimental
干预措施: Robot-assisted single-port bariatric surgery (Device)
结局指标
主要结局
Percentage of weight loss
时间窗: Postoperative 1 month, 3 months, 6 months, 12months
次要结局
- blood pressure(1 month, 3 months, 6 months, and 12 months post-surgery)
- operation time(Intraoperative)
- Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.)(12 months post-surgery)
- Physician fatigue level (Visual Analogue Scale)(1 day after surgery)
- blood sugar(1 month, 3 months, 6 months, and 12 months post-surgery)
- body fat percentage(1 month, 3 months, 6 months, and 12 months post-surgery)
- estimated blood loss(1 month after surgery)
- conversion to laparoscopic or open surgery(1 month after surgery)
- 30-day reoperation rate(1 month after surgery)
- 30-day readmission rate(1 month after surgery)
- length of postoperative hospital stay(1 month after surgery)
- Physician satisfaction level (Net Promoter Score, NPS)(1 day after surgery)
研究者
Hua Meng
Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital
China-Japan Friendship Hospital
研究点 (1)
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