The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Rate of Anastomotic Leakage
研究概览
简要总结
This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.
详细描述
This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcomes assessors will be blinded to the group assignments. Surgeons will be aware of the group assignments but will not disclose this information to the participants or the outcomes assessors.
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
- •Age between 18 and 85 years.
- •Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
- •ECOG performance status of 0 or
- •ASA (American Society of Anesthesiologists) classification of I-III.
- •Voluntary signed informed consent from the participant or their legal representative.
排除标准
- •Evidence of potential distant metastasis found preoperatively.
- •History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
- •Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
- •Participation in any other clinical trial within the last 6 months.
- •Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.
结局指标
主要结局
Rate of Anastomotic Leakage
时间窗: 30 days post-surgery
The incidence of anastomotic leakage within 30 days post-surgery. Anastomotic leakage is defined as the presence of fluid containing enteric content in the abdominal cavity or the appearance of leakage confirmed by imaging or endoscopy.
次要结局
- Rate of Anastomotic Stricture(3 months post-surgery)
- Postoperative Bleeding Rate(30 days post-surgery)
- Mortality Rate(30 days post-surgery)
- Readmission Rate(3 months post-surgery)
研究者
Yunhong Tian
Professor
Nanchong Central Hospital