Comparison of Gallbladder Extraction Via the Subxiphoid Port and the Infraumbilical Port During Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean Postoperative Pain Score
研究概览
简要总结
Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can influence wound-related morbidity.
Traditionally, the gallbladder is extracted through the infraumbilical port site. While effective, this route is associated with a potential risk of port-site infections due to bacterial colonization within the umbilicus and risk of contamination during specimen extraction. Retrieving the gallbladder through the subxiphoid port has been proposed as an alternative technique that may utilize a cleaner surgical site, potentially reducing patient pain scores and regional wound complications.
This prospective randomized clinical trial aims to directly compare the clinical outcomes of extracting the gallbladder through the subxiphoid port versus the traditional infraumbilical port. The study will evaluate and compare mean postoperative pain intensity within the first 24 hours, as well as the regional development of port-site infections, seromas, or hematomas within 7 days following elective laparoscopic surgery.
详细描述
This study is structured as a parallel-group randomized controlled trial conducted at Mayo Hospital, Lahore, to evaluate the optimal retrieval site for specimen extraction during elective laparoscopic cholecystectomy.
Eligible patients aged 18 to 60 years diagnosed with symptomatic gallstone disease who meet all predefined inclusion criteria will be invited to participate. All surgical procedures will be standardized and performed under general anesthesia by a senior consultant surgeon using a conventional four-port technique. Following the successful mobilization of the gallbladder, the specimen will be enclosed safely inside a sterile endo-bag to control potential bile contamination.
Patients will then be dynamically allocated via a computer-generated randomization system into one of two surgical groups:
- Group A (Experimental Arm): The endo-bag containing the gallbladder is carefully retrieved through the subxiphoid port site under direct vision.
- Group B (Active Comparator Arm): The endo-bag containing the gallbladder is retrieved through the primary infraumbilical camera port site under direct vision.
Postoperatively, all participating patients will be systematically tracked for primary and secondary outcomes. Postoperative physical distress will be quantified while the patient is at rest using a 10-point Visual Analogue Scale (VAS) at regular intervals of 6, 12, and 24 hours. Additionally, specialized clinical assessments will be performed through the first 7 postoperative days to monitor and log the occurrence of port-site infections, staged using the Southampton Wound Classification system, alongside local complications including seroma or hematoma formation.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 to 60 years.
- •Diagnosed with symptomatic gallstones on ultrasonography.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Scheduled for elective laparoscopic cholecystectomy.
- •Presence of acute or empyematous cholecystitis
排除标准
- •Intraoperative conversion to open cholecystectomy.
- •Diagnosed with Diabetes mellitus type 2.
结局指标
主要结局
Mean Postoperative Pain Score
时间窗: At 6, 12, and 24 hours post-surgery
Postoperative pain intensity will be assessed while the patient is at rest using a 10-point Visual Analogue Scale (VAS), where 0 represents "No Pain" and 10 represents "Worst Possible Pain".
次要结局
- Incidence of Port-Site Infection(Up to 7 postoperative days)
- Incidence of Local Wound-Related Complications(Up to 7 postoperative days)