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Completed

NCT Number: NCT05121181

Reaching Consensus on the Definition of Difficult Cholecystectomy

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%.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Alba Manuel Vázquez

Madrid, 28902, Spain

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not Spanish
  • not experts in laparoscopic cholecystectomy.

Treatment and study plan

delphi project

Other

delphy study

Primary outcomes

  1. consensus

    Time frame: 1 month

    Likert scale: 1: "totally disagree", 2: "disagree", 3: "neither agree nor disagree", 4: "agree", and 5: "totally agree".

Sponsors and collaborators

Lead sponsor

Candido Fernando Alcazar-Lopez

Other

Collaborators

  • Complejo Hospitalario Universitario de Badajoz
  • Hospital Miguel Servet
  • Hospital Universitario Getafe

Registry information

Official study title

Reaching Consensus on the Definition of Difficult Cholecystectomy Among Spanish Experts. A Delphi Project. Qualitative Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Nov 16, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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