Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .

Study Overview
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Brief Summary
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Cholecystectomy is the most common procedure in biliary surgery which may be open or laparoscopic.laparoscopic cholecystectomy is widely accepted as the gold standard technique in both adults and children .over recent years there has been a significant increase in paediatric cholecystectomies alongside a rising incidence of childhood gall stones.

Detailed Description
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The majority of paediatric gallstones are related to haemolytic diseases such as hereditary spherocytosis. In recent decades, the incidence of gallstone disease in children has risen which may be related to the epidemic of paediatric obesity and improved survival of critically ill neonates who have received long-term total parenteral nutrition or correction of abnormalities resulting in increased incidence of cholelithiasis in the paediatric population such as short gut syndrome.The rate of conversion to open cholecystectomy ranges between 2% and 20%. Certain preoperative and operative factors can reliably predict the chances of conversion to the open procedure. Until recently large studies are lacking of assessment of the risk factors that my be responsible for conversion of laparoscopic cholecystectomy to open cholecystectomy . This study aims to assess preoperative and operative risk factors for conversion to open surgery .

Official Title
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Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .

Conditions
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Laparoscopic Cholecystectomy in Children

Intervention / Treatment
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* Procedure: laparscopic Cholecystectomy in children


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit. fit for surgery Exclusion Criteria: patients with co-existent common bile duct stones based on imaging and biochemical criteria. Patients with Pancreatitis . Patients with previous upper abdominal surgery. 5_Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laparoscopic Cholecystectomy in children<br>Evaluate preoperative and operative risk factors for laparoscopic cholecystectomy compared to open cholecystetcomy | Procedure: laparscopic Cholecystectomy in children<br>* Evaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy<br>* Other names: open Cholecystectomy in children;|
| Other: Open Cholecystectomy in children<br>Evaluate preoperative and operative risk factors for open cholecystectomy compared to laparoscopic cholecystetcomy | Procedure: laparscopic Cholecystectomy in children<br>* Evaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy<br>* Other names: open Cholecystectomy in children;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholecystectomy in children | Evaluate and the risk factors for conversion of laparoscopic to open cholecystectomy | one year |