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

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05859607

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Chronic Calculous Cholecystitis	Procedure: laparoscopic cholecystectomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 18, 2023

Anticipated Primary Completion Date :

Oct 18, 2023

Anticipated Study Completion Date :

Oct 18, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Validation and applicability of scoring systems [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University Hospital	Sohag		Egypt

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud Fahmy Mahmoud, resident doctor at General surgery department, Sohag University

ClinicalTrials.gov Identifier:

NCT05859607

Other Study ID Numbers:

Soh-Med-23-03-14MS

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cholecystitis

Study Results

No Results Posted as of May 16, 2023