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

NCT05859607 | Unknown

• 1 other identifier: Soh-Med-23-03-14MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Chronic Calculous Cholecystitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Easy cholecystectomy

ACTIVE COMPARATOR

easy procedure with no complications

Procedure: laparoscopic cholecystectomy

moderate severe cholecystectomy

ACTIVE COMPARATOR

moderate severity with prolonged time or complication .

Procedure: laparoscopic cholecystectomy

difficult cholecystectomy

ACTIVE COMPARATOR

very prolonged time , complication or conversion to open cholecystectomy .

Procedure: laparoscopic cholecystectomy

Interventions

laparoscopic cholecystectomy PROCEDURE

conventional laparoscopic cholecystectomy with calculation of difficulty scorings

Easy cholecystectomy; difficult cholecystectomy; moderate severe cholecystectomy

Eligibility Criteria

• Age: 15 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with symptomatic gall stones

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Central Study Contacts

Mahmoud F Mahmoud, resident

CONTACT

01159771450; mahmoudfahmy@med.sohag.edu.eg

Alaa A Radwan, professor

CONTACT

01001988455

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at General surgery department

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 16, 2023
• Study Start: April 18, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

EG (1)