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NCT05121181

Reaching Consensus on the Definition of Difficult Cholecystectomy

Completed Last updated 16 November 2021
What this trial tests

trial testing delphi project in Cholelithiasis in 46 participants. Completed in 1 January 2021.

Timeline
1 July 2020
Primary endpoint
15 November 2020
1 January 2021

Quick facts

Lead sponsorCandido Fernando Alcazar-Lopez
StatusCompleted
Study typeOBSERVATIONAL
Enrollment46
Start date1 July 2020
Primary completion15 November 2020
Estimated completion1 January 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Candido Fernando Alcazar-Lopez

Who can join

Eligibility, any sex, with Cholelithiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Cholelithiasis

Currently open trials in the same condition.

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