Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).
研究概览
简要总结
To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.
详细描述
To date, no studies have compared the outcomes of thulium beam coagulation versus suture renorrhaphy for hemostasis of tumor bed in laparoscopic partial nephrectomy in patients with small renal messes (SRMs).
This study aims to compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.
The investigators hypothesize that:
Conducted well designed, randomized prospective comparative study can help to identify which technique is better.
Using thulium beam coagulation for hemostasis of the tumor bed in laparoscopic partial nephrectomy can improve the outcome, shorten intraoperative ischemia time and decrease blood loss.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cT1 single renal mass.
排除标准
- •Absolute contraindication for laparoscopic surgery (e.g., severe cardiopulmonary insufficiency, and chronic obstructive lung disease).
- •Renal mass involving the hilum.
- •Renal mass in patients with chronic kidney disease.
研究组 & 干预措施
suture renorrhaphy group
involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.
干预措施: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy (Procedure)
thulium beam coagulation group
involves cases of laparoscopic partial nephrectomy with thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed
干预措施: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy (Procedure)
结局指标
主要结局
Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).
时间窗: during the surgery
Started once renal artery clamped before tumor enucleation till release of the clamp after 1st layer renorraphy in group 1 or Thulium beam coagulation in group 2
Intraoperative number of sutures for renorraphy
时间窗: during the surgery
which is the count of each time the needle comes out from the renal parenchyma.
Intraoperative Blood loss
时间窗: during the surgery
Blood loss will be calculated from the suction jar minus the amount of fluid irrigation
Blood transfusion rate
时间窗: perioperatively
Amount of blood in ml transfused intraoperative or postoperative
Renal function: serum creatinine
时间窗: 3 months
will be estimated by serum creatinine. Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function
Renal function: estimated GFR (eGFR)
时间窗: 3 months
ill be estimated by estimated GFR (eGFR) using Modification of Diet in Renal Disease (MDRD) equation (Levey et al., 2006). Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function
Transforming growth factor beta (TGF-β) urine level
时间窗: pre-surgery, at 24 hours and at 1 month
will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN
Suture time and operative time in minutes
时间窗: during the surgery
Suture time starts from the first suture to the last one, including time of manipulating needles.
Monocyte chemoattractant protein (MCP-1) urine level
时间窗: pre-surgery, at 24 hours and at 1 month
will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN
次要结局
- Hospital stay(perioperatively)
- Post operative pain(perioperatively)
研究者
Ehab Mohammed Ali Atallah
Assistant lecturer
Al-Azhar University