Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes , Sohag Experience.

Predictors of Difficult Laparoscopic Cholecystectomy, Scoring Systems and Their Implications on the Outcomes, Sohag Experience.

laparoscopic cholecystectomy nowadays is the most common surgery done by General surgery surgeons , so it is necessary to evaluate the difficulty of each case prior to surgery and from the first look ,to avoid complications and improve outcomes , so scoring systems are needed for better assessment of the overall condition and make good decision .

Study Overview

• Status: Recruiting
• Conditions: Chronic Calculous Cholecystitis
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud F Mahmoud, resident; Phone Number: 01159771450; Email: mahmoudfahmy@med.sohag.edu.eg
• Study Contact Backup: Name: Alaa A Radwan, professor; Phone Number: 01001988455

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients with symptomatic gall stones

Exclusion Criteria:

• lap to open conversion due to equipment failure pregnancy common bile duct stone obstructive jaundice unfit for general anesthesia patients refusing lap cholecystectomy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Easy cholecystectomy; easy procedure with no complications	Procedure: laparoscopic cholecystectomy; conventional laparoscopic cholecystectomy with calculation of difficulty scorings
Active Comparator: moderate severe cholecystectomy; moderate severity with prolonged time or complication .	Procedure: laparoscopic cholecystectomy; conventional laparoscopic cholecystectomy with calculation of difficulty scorings
Active Comparator: difficult cholecystectomy; very prolonged time , complication or conversion to open cholecystectomy .	Procedure: laparoscopic cholecystectomy; conventional laparoscopic cholecystectomy with calculation of difficulty scorings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation and applicability of scoring systems	the scoring system should reach high percentage to be applicable and could be used for scoring difficulty.A comparison between preoperative score and intraoperative score, then the success of a scoring system is by the high percentage sensitivity ,preoperative data sheet will be taken from all patients ,then the first look intraoperative will judge the score through multiple items , the cross matching will be done between the two scores. and to measure the results,There are many scoring system for example Randawa preoperative and intraoperative score , Nassar preoperative and intraoperative score ,matching the result of both preoperative and intraoperative will be done to validate each one. Randawa score classified into easy and moderate and severe difficulty based on time lapsed during cholycystectomy ,intraoperative problems and complications Nassar uses the intraoperative shape of gall bladder to classify the difficulty from 1 to 5 grades upon the first look to the gall bladder.	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Anticipated): October 18, 2023
• Study Completion (Anticipated): October 18, 2023

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: Soh-Med-23-03-14MS

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