Reaching Consensus on the Definition of Difficult Cholecy... | NCT05121181

Studies
Reaching Consensus on the Definition of Difficult Cholecystectomy

NCT05121181

Sponsor

Candido Fernando Alcazar-Lopez

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Cholelithiasis

Interventions

delphi project

Countries

Spain

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

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jul 22, 2021

First Submission Date that Met QC Criteria

Nov 3, 2021

First Posted Date

Nov 16, 2021Actual

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

Nov 3, 2021

Last Update Posted Date

Nov 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Candido Fernando Alcazar-Lopez, Doctor, Hospital General Universitario de AlicanteSponsor-Investigator

Lead Sponsor

Candido Fernando Alcazar-LopezOTHER

Collaborators

Name	Class
Hospital Universitario Getafe	OTHER
Complejo Hospitalario Universitario de Badajoz	OTHER
Hospital Miguel Servet	OTHER

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

Being able to predict the difficulty of a preoperatively can increase safety and improve results. However, a consensus must be reached regarding the definition of a cholecystectomy as "difficult". The aim of this study is to achieve a national expert consensus.

Methods A Delphi study was conducted. Based on the literature, a history of biliary pathology, preoperative clinical, analytical, and radiological data, and intraoperative findings were selected and rated on a Likert scale.

Inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the Likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

Detailed Description

A Delphi study was conducted. Inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the Likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

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

46Actual

Name	Type	Description	Arm Group Labels	Other Names
delphi project	Other	delphy study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
consensus	Likert scale: 1: "totally disagree", 2: "disagree", 3: "neither agree nor disagree", 4: "agree", and 5: "totally agree".	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Spanish surgeons
experts in laparoscopic cholecystectomy, with more than 10 years of experience

Exclusion Criteria:

not Spanish
not experts in laparoscopic cholecystectomy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Spanish experts in laparoscopic cholecystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alba Manuel Vázquez, Dr	Hospital Universitario de Getafe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alba Manuel Vázquez		Madrid		28902	Spain

Condition Browse Module

MeSH Terms

ID	Term
D002769	Cholelithiasis

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided