Retrieval of Gallbladder through Umbilical Versus Epigastric Port during Laparoscopic Cholecystectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Post-operative pain using Visual Analogue Scale post-operatively at 12 hours, 24 hours and 48 hours for both the groups.
研究概览
简要总结
Laparoscopic cholecystectomy (LC) is the gold standard procedure for
managing patients with symptomatic gall bladder diseases
GB is usually extracted after LC either from the epigastric or umbilical port
According to review of literature epigastric port for GB retrieval is preferred
due to the surgeon’s ease and also as there was no need to change the
position of the telescope, however, retrieval through umbilical port has
less post-operative pain as mentioned in few studies.
Therefore, till date, there is no level 1 evidence or meta- analysis to
support the superiority of one port over another for GB extraction in terms
of postoperative port- site pain
This study is undertaken to compare gall bladder (GB) retrieval from
umbilical port with epigastric port in terms of post-operative pain, port site
infection, retrieval time and port site herniation in adult patients
undergoing elective laparoscopic cholecystectomy
E
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients coming for elective laparoscopic cholecystectomy shall be included in the trial.
排除标准
- •Patient with comorbidities like uncontrolled Diabetes Mellitus, Immuno-suppresive conditions.
- •Patients with intra-operative spillage of bile.
结局指标
主要结局
Post-operative pain using Visual Analogue Scale post-operatively at 12 hours, 24 hours and 48 hours for both the groups.
时间窗: At 12 hours, 24 hours, 48 hours
次要结局
- Port-site infection will be evaluated using Southampton grading.(Day 5,7, 14)
- Any incidence of port site hernia(To be noted in 6 month follow up period)