Clinical trial NCT06048029: Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .
Official title: Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laparoscopic Cholecystectomy in Children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 .

Eligibility criteria: Inclusion Criteria:

1. Patients with age less than 18 years old presented to assiut university hospitals at pediatric surgeey unit.
2. fit for surgery

Exclusion Criteria:

1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.
2. Patients with Pancreatitis .
3. Patients with previous upper abdominal surgery.

5_Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Chronic Pulmonary Disease, significant Cardiac Disease)

Primary outcomes:
measure: Cholecystectomy in children
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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