NCT05121181

Brief 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

July 22, 2021

Last Update Submit

November 3, 2021

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • consensus

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

    1 month

Interventions

delphi projectOTHER

delphy study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Spanish experts in laparoscopic cholecystectomy

You may qualify if:

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

You may not qualify if:

  • not Spanish
  • not experts in laparoscopic cholecystectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alba Manuel Vázquez

Madrid, 28902, Spain

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Alba Manuel Vázquez, Dr

    Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 22, 2021

First Posted

November 16, 2021

Study Start

July 1, 2020

Primary Completion

November 15, 2020

Study Completion

January 1, 2021

Last Updated

November 16, 2021

Record last verified: 2021-11

Locations

ES(1)