Retrieval of Gallbladder by Improvised Endobag Versus Direct Extraction in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visible perforation of the gallbladder developed during gallbladder removal
研究概览
简要总结
Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded.
During surgery, the method used to remove the gallbladder, the port used for extraction, and the duration of surgery will be documented. Any gallbladder perforation, leakage of bile, or spillage of gallstones during the procedure will also be recorded.
After surgery, patients will be monitored in the hospital for 24 hours. Their pain will be assessed before discharge. Patients will then be followed in the outpatient clinic for 10 days to assess wound healing and identify any wound infection or other complications.
The study aims to compare the safety and effectiveness of an improvised retrieval bag with removal of the gallbladder without a retrieval bag during laparoscopic surgery.
详细描述
Eligible patients undergoing laparoscopic cholecystectomy will be enrolled after obtaining written informed consent. Baseline demographic and clinical characteristics, including age, gender, body mass index, smoking and alcohol history, hypertension, number of gallstones, and gallbladder wall thickness, will be recorded.
Patients will be randomly allocated to receive one of the predefined gallbladder extraction techniques. The port site used for gallbladder retrieval and total operative time will be documented. Intraoperative events, including gallbladder perforation, bile spillage, and stone spillage, will be recorded according to predefined operational definitions.
All procedures will be performed under general anesthesia by the same surgical team. Wound closure will be performed by the researcher using a standardized technique to minimize procedural variability and potential bias.
Following surgery, patients will be monitored in the postoperative ward for 24 hours. Postoperative pain will be assessed using a standardized pain score before discharge. Patients will subsequently be followed in the outpatient department for 10 days, during which the surgical wound will be assessed for infection and other relevant postoperative 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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective Laparoscopic Cholecystectomy
排除标准
- •Patients having common bile duct stones or dilatation
- •Acute cholecystitis, gallbladder perforation, malignancy (on medical record).
- •Patients requiring conversion to open cholecystectomy, ASA III-IV
- •Patients with skin diseases near wound site, diabetes (HbA1c>6.5%), and Hb <10gm/dl
研究组 & 干预措施
Group Endobag
干预措施: Endobag (Device)
Group Control
干预措施: placebo group (Device)
结局指标
主要结局
Visible perforation of the gallbladder developed during gallbladder removal
时间窗: Perioperative/Periprocedural
Surgical Time
时间窗: This will be the time in minutes measured Peri-procedurally from skin incision to skin closure
Visible spillage of bile from the gallbladder during gallbladder removal
时间窗: Perioperative/Periprocedural (at the time of gallbladder removal)
Visible spillage of gallstones from the gallbladder during gallbladder removal
时间窗: Perioperative/Periprocedural
Port site pain
时间窗: It will be assessed using Visual Analog scale at 24 hours post procedure
次要结局
未报告次要终点
研究者
Sadia Ali
Principal Investigator
Rawal Institute of Health Sciences Islamabad