Reaching Consensus on the Definition of Difficult Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05121181
• Other study ID #: 0
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2021
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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%.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 1, 2021
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Spanish surgeons

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

Exclusion Criteria:

• not Spanish

• not experts in laparoscopic cholecystectomy.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Other:
• delphi project
delphy study

Locations

Country	Name	City	State
Spain	Alba Manuel Vázquez	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Candido Fernando Alcazar-Lopez	Complejo Hospitalario Universitario de Badajoz, Hospital Miguel Servet, Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consensus	Likert scale: 1: "totally disagree", 2: "disagree", 3: "neither agree nor disagree", 4: "agree", and 5: "totally agree".	1 month