Early Versus Delayed Laparoscopic Cholecystectomy aftermanagement of Choledocholithiasis with Endoscopic Retrograde CholangioPancreatography (ERCP) - A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the appropriate time at which cholecystectomy should be done post ERCP.
研究概览
简要总结
Laparoscopic cholecystectomy preceded by pre-operative ERCP remains the cornerstone and most commonly practiced strategy worldwide for management of co-existing gallbladder and CBD stones.However there is difference in opinion as to the time interval between performing the two procedures. There is a surgeon-to-surgeon difference in preferences with various factors coming into play.
Purpose of trial: This study is to analyse the various factors that impact this decision and to conclude if performing the surgery early(within 48 hours) is better or late(after 6 weeks)
Major drawback of delaying Laparoscopic Cholecystectomy are high incidence of biliary complications like bile spill, stone spill and occurence of intra-operative adhesions.
Major drawbacks of early Laparoscopic Cholecystectomy is difficult handling of structures that are in a setting of ongoing inflammation.
This study is to analyse the benefits and disadvantages of each approach from both
1. Surgeon’s point of view- Duration of surgery, Intra-op adhesions, intra / post-op complications
- Patient’s point of view- Hospital stay, cost profile
Methodology-
Retrospective samples -
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Patients who underwent ERCP for choledocholithiasis (under Department of Gastroenterology) followed by laparoscopic cholecystectomy (under the Department of General Surgery) in Kasturba Hospital, Manipal will be included in the study after fulfilling the inclusion and exclusion criteria.
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Requisite pre-op laboratory values, intra-op op & post-operative parameters will be noted from the patient’s medical records.
Prospective samples-
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Patients satisfying inclusion criteria will be chosen by closely following the ERCP list performed by Gastroenterology.
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Patients among these who are then referred to General Surgery department for Post-ERCP Laparoscopic Cholecystectomy will be decided for early or late Laparoscopic Cholecystectomy based on
surgeon’s preference.
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At this point, informed consent will be taken from the patient to include them in the study.
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Pre-op- Lab values will be noted. - Total leukocyte count, Total & Direct Bilirubin, Liver enzymes
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Intra-op- Operation will be observed for - duration of surgery, status of calot’s triangle, intra-abdominal adhesions
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Post-op- Patient will be followed up on a daily basis to note - bile leak, surgical site infection, sepsis
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Total hospital stay & costs incurred to patient will be noted.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Documented radiological evidence of choledocholithiasis.
- •Management of CBD Stones with ERCP.
排除标准
- •Carcinoma of Gall Bladder
- •Previous abdominal surgeries.
结局指标
主要结局
To assess the appropriate time at which cholecystectomy should be done post ERCP.
时间窗: within 48 hours or after 6 weeks
次要结局
- To analyse how the time gap between ERCP and cholecystectomy affects(the duration of surgery.)
- To evaluate if there is a higher conversion rate of laparoscopic(cholecystectomy to open cholecystectomy with the increasing duration of)
- To assess the duration of hospital stay, outcome, complications, cost(profile in both set of patients.)