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Reaching Consensus on the Definition of Difficult Cholecystectomy

NCT ID: NCT05121181

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-01-01

Brief Summary

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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

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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%.

Conditions

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Cholelithiasis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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delphi project

delphy study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not Spanish
* not experts in laparoscopic cholecystectomy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Getafe

OTHER

Sponsor Role collaborator

Complejo Hospitalario Universitario de Badajoz

OTHER

Sponsor Role collaborator

Hospital Miguel Servet

OTHER

Sponsor Role collaborator

Candido Fernando Alcazar-Lopez

OTHER

Sponsor Role lead

Responsible Party

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Candido Fernando Alcazar-Lopez

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alba Manuel Vázquez, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Getafe

Locations

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Alba Manuel Vázquez

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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0

Identifier Type: -

Identifier Source: org_study_id