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临床试验/CTRI/2024/11/077088
CTRI/2024/11/077088尚未招募不适用

Clinical, Biochemical and Imaging Outcomes Following Difficult Laparoscopic Cholecystectomy: An Ambispective Study

未提供1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年12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
75
试验地点
1
主要终点
To assess short term surgical, symptomatic and biochemical outcomes at 3 months in patients undergoing difficult cholecystectomy in prospective arm

研究概览

简要总结

Laparoscopic Cholecystectomy is considered the gold standard procedure for gall stone diseases. Laparoscopic cholecystectomy has shown to improve symptoms and quality of life in patients suffering from symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy for difficult gall bladders, including subtotal cholecystectomy, also report positive improvements in symptoms and quality of life post-surgery. But these patients tend to have longer hospital stay attributed to SSI, readmission and intervention for retained stones, bile leak in post operative period. These complications can impact on quality of life in longer times. 

This study aim to assess the outcome of difficult laparoscopic cholecystectomy in terms of clinical, biochemical and imaging parameters.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients who underwent laparoscopic cholecystectomy meeting with working definition of difficult laparoscopic cholecystectomy.

排除标准

  • Malignancy on histopathology Refusal to consent Lost to follow up.

结局指标

主要结局

To assess short term surgical, symptomatic and biochemical outcomes at 3 months in patients undergoing difficult cholecystectomy in prospective arm

时间窗: 3 months & 1 year

• To assess long term symptomatic, biochemical and radiological outcomes at minimum 1 year in patients undergoing difficult cholecystectomy

时间窗: 3 months & 1 year

次要结局

  • Assess Quality of Life using GIQLI (Gastro Intestinal Quality of Life Index) at 3-6 months in patients undergoing difficult cholecystectomy in prospective arm(3-6 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Mohammed Motiwala

AIIMS

研究点 (1)

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