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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06048029
Collaborator
(none)
40
Enrollment
2
Arms
24.2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparscopic Cholecystectomy in children
 N/A

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 .

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Laparoscopic Cholecystectomy in Children. Risk Factors for Conversion. A Prospective Study .
Anticipated Study Start Date :
Dec 3, 2023
Anticipated Primary Completion Date :
Dec 10, 2024
Anticipated Study Completion Date :
Dec 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Laparoscopic Cholecystectomy in children

Evaluate preoperative and operative risk factors for laparoscopic cholecystectomy compared to open cholecystetcomy

Procedure: laparscopic Cholecystectomy in children
Evaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy
Other Names:
  • open Cholecystectomy in children

    		•
    Other: Open Cholecystectomy in children

    Evaluate preoperative and operative risk factors for open cholecystectomy compared to laparoscopic cholecystetcomy

    Procedure: laparscopic Cholecystectomy in children
    Evaluate preoperative and operative risk factors for conversion of laparoscopic cholecystectomy to open cholecystectomy
    Other Names:
  • open Cholecystectomy in children

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cholecystectomy in children [one year]

      Evaluate and the risk factors for conversion of laparoscopic to open cholecystectomy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahmoud Mohamed Korashy, primary investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06048029
    Other Study ID Numbers:
    • Cholecystectomy
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 21, 2023