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临床试验/CTRI/2024/10/075633
CTRI/2024/10/075633尚未招募不适用

A Randomized Controlled Trial To Compare The Outcomes Between The Conventional And Modified Epigastric Port Insertion Techniques In Laparoscopic Cholecystectomy

All India Institute of Medical Sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
104
试验地点
1
主要终点
To compare the postoperative epigastric port site pain using VAS score between the conventional and modified epigastric port insertion techniques in laparoscopic cholecystectomy

研究概览

简要总结

Laparoscopic cholecystectomy (LC) is one of the most frequently done abdominal surgeries and is the standard of care for symptomatic cholelithiasis. LC is associated with good surgical results, insignificant blood loss, reduced severity of postoperative pain, and early discharge. Port site pain depends on the type and the method of trocar insertion as well as the nociceptive impulse can be from both the skin incision and the muscle damage and intramuscular hematoma that can occur during the port insertion. One of the important aspects of laparoscopic cholecystectomy is the proper port position in relation to the target organ of dissection. Although there is no controversy about the position of umbilical, right  subcostal (midclavicular) and right anterior axillary ports in laparoscopic cholecystectomy, but there is no uniform consensus about the position of epigastric port. Conventionally epigastric port is inserted to the right of falciform ligament. In literature, position to the left of ligament is also mentioned. As in the modified technique of epigastric port insertion the port is inserted directly under vision through the linea alba instead of the muscle fibres there is less expected chances of muscle injury and intramuscular bleed. Lack of literature comparing both the above-mentioned techniques of epigastric port insertion especially with respect to the epigastric port site pain.The purpose of this study is to define the optimal epigastric port position for laparoscopic cholecystectomy by comparing the outcomes between conventional and modified epigastric port insertion techniques in laparoscopic cholecystectomy  with respect to parameters like postoperative pain, total requirement of postoperative analgesia, gallbladder retrieval time, total duration of surgery and port site infection (SSI).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing elective laparoscopic cholecystectomy in the age group of 18 years and above.

排除标准

  • Suspected malignancy 2)Pregnant patient 3)Frozen calots with or without surrounding dense adhesions 4)Patients who require CBD exploration 5)Cases that get converted to open 6)Patients with portal hypertension.

结局指标

主要结局

To compare the postoperative epigastric port site pain using VAS score between the conventional and modified epigastric port insertion techniques in laparoscopic cholecystectomy

时间窗: 6 hours, 12 hours and 24 hours

次要结局

  • To compare the time taken for extraction of gall bladder between the(modified epigastric port insertion group and conventional epigastric port)
  • To compare the total duration of surgery between the modified epigastric(port insertion group and the conventional epigastric port group in)
  • To compare the 30 day epigastric wound complication rate using(Southampton scale between both the groups.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Arunkumar V

All India Institute of Medical Sciences, Rishikesh

研究点 (1)

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