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

September 15, 2023 updated by: Mahmoud Mohamed Korashy, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 3, 2023

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Cholecystectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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