D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy In Right Cancer Colon Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of lymph node harvesting in the final specimen
研究概览
简要总结
Evaluating the differences between D2 and D3 lymphadenectomy in laparoscopic right hemicolectomy in patients with right cancer colon post-operative outcome, intra-operative blood transfusion, post-operative ICU admission, anastomotic leakage, lymph node harvesting in the final specimen, and six months follow up and overall survival time after 5-years
详细描述
Surgical Technique and Preparation Enoxaparin sodium 40 mg subcutaneous injection will be administered 12 hours before the operation, and Levofloxacin 500 mg intravenous injection will be administered 1 hour before the operation.
Procedures will be performed under general anesthesia.
Group A:
Location of trocars and surgeons:
The patient will be placed in the Trendelenburg position and tilt to the left, with the surgeon standing between the patient's legs, the camera operator standing on the patient's left side, the assistant standing on the right of the camera operator, and the scrub nurse standing on the patient's right side.
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 (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with right-side colon cancer (caecum, ascending, or hepatic flexure)
- •Diagnosed by CT entero-colonography
- •Diagnosed by colonoscopy
- •Diagnosed by biopsy.
排除标准
- •Emergency surgery (obstruction, perforation with generalized peritonitis),
- •Metastatic tumor diagnosed
- •ASA score of IV or higher
- •Need for more than one surgical procedure
- •Conversion to open surgery
研究组 & 干预措施
Laparoscopic hemicolectomy with Complete Mesocolic Excision
Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.
干预措施: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (intervention) (Procedure)
Laparoscopic hemicolectomy with Complete Mesocolic Excision
Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.
干预措施: Enoxaparin 40 Mg/0.4 mL Injectable Solution (Drug)
Laparoscopic hemicolectomy with Complete Mesocolic Excision
Patients will have laparoscopic hemicolectomy with Complete Mesocolic Excision, D3 lymph node dissection.
干预措施: Levofloxacin 500mg (Drug)
Conventional laparoscopic right hemicolectomy
Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.
干预措施: Enoxaparin 40 Mg/0.4 mL Injectable Solution (Drug)
Conventional laparoscopic right hemicolectomy
Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.
干预措施: Levofloxacin 500mg (Drug)
Conventional laparoscopic right hemicolectomy
Patients will have conventional laparoscopic right hemicolectomy with D2 lymph node dissection.
干预措施: LAPAROSCOPIC RIGHT HEMICOLECTOMY procedure (Conventional) (Procedure)
结局指标
主要结局
Number of lymph node harvesting in the final specimen
时间窗: 6 months post-operative
incidence of lymph node
Number of post-operative ICU admission
时间窗: immediately after the intervention/procedure/surgery
Incidence of ICU admission after surgery
Number of blood units needed
时间窗: during the intervention/procedure/surgery
Guided by hemoglobine levels during surgery
Number of postoperative outcomes
时间窗: 6 months post-operative
the medical condition from the patient
Number of anastomotic leakage
时间窗: Within 30 days post-operative
incidence of anastomotic leakage
次要结局
- Overall survival time after 5-years(5 years post-operative)
研究者
Mohamed Hany Ashour
Principal Investigator
General Committee of Teaching Hospitals and Institutes, Egypt