Reaching Consensus on the Definition of Difficult Cholecystectomy

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

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%.

Study Overview

• Status: Completed
• Conditions: Cholelithiasis
• Intervention / Treatment: Other: delphi project

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%.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28902
    • Alba Manuel Vázquez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Spanish experts in laparoscopic cholecystectomy

Description

Inclusion Criteria:

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

Exclusion Criteria:

• not Spanish
• not experts in laparoscopic cholecystectomy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Candido Fernando Alcazar-Lopez
• Collaborators: Hospital Universitario Getafe; Hospital Miguel Servet; Complejo Hospitalario Universitario de Badajoz
• Investigators: Principal Investigator: Alba Manuel Vázquez, Dr, Hospital Universitario de Getafe

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): November 15, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: Institute of Psychiatry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No