Comparison Between Metallic Clip Ligation and Suture Ligation of Appendicular Stump in Laparoscopic Appendectomy, a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Length of surgery
研究概览
简要总结
Laparoscopic appendectomy is the standard procedure for acute appendicitis. Among the various steps of the procedure one of the rate limiting step is the ligation of the appendicular stump which can be done using suture material, metallic clips and hem o loks. This study compares the effect the using metallic clips versus suture material in the ligation of appendicular stump in terms of length of surgery and associated intra-operative complications. The patients included will be within the age group of 15-60 years, with BMI of 18-28kg/m2, and with acute appendicitis of upto grade 3. The data will be analyzed using SPSS a p value of <0.05 will be considered as statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders, within the age bracket of 15 years - 60 years.
- •With a BMI within the range of 18 - 28 kg/m
- •With a diagnosis made by a consultant surgeon and the grade of appendicitis upto 3.
排除标准
- •Patients with long standing comorbidities including chronic liver disease, diabetes mellitus, chronic kidney disease and hemorrhagic disorders.
- •Patients taking anticoagulants, carrier of active cases of Hepatitis B, C and/or HIV.
- •Patients on immunosuppression therapy. Diameter of appendicular stump of more than 10mm, perforated appendix, laparoscopic appendectomy converted to open appendectomy pelvic appendicitis and sub-hepatic appendicitis.
研究组 & 干预措施
Group A - Patients undergoing metallic clip ligation
One of the standard methods of appendicular stump ligation
干预措施: Metallic clip ligation of the appendicular stump (Device)
Group B - Patients undergoing suture material ligation of appendicular stump
A feasible testing method with an anticipated increase in the length of surgery
干预措施: Suture ligation of appendicular stump (Device)
结局指标
主要结局
Length of surgery
时间窗: Intraoperative
The length of surgery will be measured in terms of minutes from the start of the pneumoperitoneum insufflation till the evacuation of the pneumoperitoneum at the conclusion of the surgery.
次要结局
未报告次要终点
研究者
MUHAMMAD SAUD IQBAL
Post-graduate resident, Principal Investigator
Jinnah Hospital