Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Average operative time (in minutes).
研究概览
简要总结
This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
- •Patients who have undergone a complete (R0) resection.
- •Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
- •Patients undergoing robotic radical distal gastrectomy.
排除标准
- •Patients under 19 years of age.
- •Patients who have received preoperative chemotherapy or radiotherapy.
- •Patients diagnosed with stage IV gastric cancer due to distant metastasis.
- •Patients diagnosed with malignancies other than gastric cancer.
- •Patients scheduled to undergo total gastrectomy.
- •Patients requiring total omentectomy.
研究组 & 干预措施
Assistant-Controlled Group
The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system.
干预措施: Arm I (Assistant-Controlled Laparoscopic Instrumentation) (Procedure)
Full Robotic Group
The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler.
干预措施: Arm II (Assistant-Controlled Laparoscopic Instrumentation) (Procedure)
结局指标
主要结局
Average operative time (in minutes).
时间窗: At the end of the surgery
The primary outcome is the average operative time (in minutes) from skin incision to skin closure. This measurement will compare surgical efficiency between the assistant-controlled laparoscopic instrumentation group and the full robotic instrumentation group.
次要结局
- Total cost of consumable surgical materials.(At the end of the surgery (up to 12 hours))
- Quality of Recovery (QoR-15) scores at 72 hours postoperatively.(72 hours postoperatively)
- Incidence of postoperative complications.(Within 30 days postoperatively)
- Time to first flatus and bowel movement.(Up to 1 month after surgery)
- Postoperative laboratory markers (e.g., CRP, WBC).(Up to 5 days after surgery)
研究者
In Gyu Kwon
Assistant Professor
Gangnam Severance Hospital