‘A Prospective interventional comparative study of conventional laproscopiccholecystectomy VERSUS Indocyanine green (ICG) dye used laproscopiccholecystectomy in patients with gall stone disease in a tertiary care hospital’
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 740
- 试验地点
- 1
- 主要终点
- intra-operative BILE LEAK
研究概览
简要总结
The laparoscopic approach has greatly improved patient care throughout various surgical subspecialties. Minimizing surgical trauma has a beneficial effect on patient recovery and decreases complications. Another advantage of laparoscopy is the improved surgical view. Not only due to improved monitors, magnification and 3d view, but more recently also through image guided techniques, such as fluorescent imaging. Indocyanine green (ICG)-enhanced fluorescence was introduced in laparoscopic surgery to improve the view and provide detailed anatomical information during surgery
Primary Hypothesis :- There is an advantage of indocyanine green (INDOCYANINE GREEN DYE ) dye use in routine laproscopic surgery in the form of reduced rate of surgical complications due to identification of different anatomical variation and well defined visible tissue perfusion in patients undergoing indocyanine green (INDOCYANINE GREEN DYE ) dye enabled surgery.
Secondary Research Question 1 :-( if any) to collect the data regarding anatomical variations seen during laproscopic surgeries by indocyanine green (INDOCYANINE GREEN DYE ) dye illuminations during surgeries of gall bladder.
Primary Objectives :- To determine the effectiveness of laproscopic ICG dye used surgery during conventional laproscopic surgical practice in the form of reduced patient morbidity and mortality.
DETAILED RESEARCH PLAN: A Prospective interventional comparative study will be conducted to understand incidence, presentation, operative methods and postoperative complication of various types of laparoscopic surgeries using ICG dye. Patients diagnosed and registered will be incorporated after written informed consent of the patient. The patient will be admitted and all routine investigation will be done as per preoperative requirements. Patients will be given standard medical and surgical treatment. The data collected and will be analyzed to reach an inference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective laparoscopic surgery.
- •Patients of adult age of either sex.
- •Patients who are willing to participate with informed consent.
排除标准
- •Patients with morbid obesity.
- •Patients allergic to ICG dye.
- •Patients hemodynamically unstable for surgery.
- •Patient not willing to participate in the study.
结局指标
主要结局
intra-operative BILE LEAK
时间窗: day of surgery day zero | post operative follow up at 3 weeks | then follow up at 6 months
次要结局
- delayed Bile leak detection(anatomical variations seen due to ICG dye use)