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

Chronic Calculous Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859607
• Other study ID #: Soh-Med-23-03-14MS
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: October 18, 2023

Study information

• Verified date: May 2023
• Source: Sohag University
• Contact: Mahmoud F Mahmoud, resident
• Phone: 01159771450
• Email: mahmoudfahmy[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Chronic Calculous Cholecystitis

Intervention

Procedure:
• laparoscopic cholecystectomy
conventional laparoscopic cholecystectomy with calculation of difficulty scorings

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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