Evaluation Of Preoperative Scoring Method For Peridiction... | NCT03718572

Studies
Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy

NCT03718572

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 24, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Evaluation Studies

Interventions

Laparoscopic cholecystectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Oct 23, 2018

First Submission Date that Met QC Criteria

Oct 23, 2018

First Posted Date

Oct 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2018

Last Update Posted Date

Oct 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.

Detailed Description

Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 30 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Scoring factors			Procedure: Laparoscopic cholecystectomy
Difficulty criteria			Procedure: Laparoscopic cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic cholecystectomy	Procedure	Surgical removal of Gall bladder using laparoscopy	Difficulty criteria Scoring factors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy	Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy	6 monthes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults male and female age of or above 18 years
Symptomatic chronic calculous cholecystitis
Ultrasound confirmed Gall bladder stones

Exclusion Criteria:

Complicated chronic calculous cholecystitis
Malignant Gall bladder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults male and female age of or above 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AbdElRhman Mohamed, Dr	Contact	0201065787845		elabassi1001@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University hospitals	Recruiting	Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017081	Cholecystectomy, Laparoscopic

Ancestor Terms

ID	Term
D002763	Cholecystectomy
D001662	Biliary Tract Surgical Procedures
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided