CholelithiasisNCT05121181
Reaching Consensus on the Definition of Difficult Cholecystectomy
An observational study of Cholelithiasis, run by Candido Fernando Alcazar-Lopez at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- delphi project
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Spanish experts in laparoscopic cholecystectomy
Who may be able to join
- Spanish surgeons
- experts in laparoscopic cholecystectomy, with more than 10 years of experience
Who cannot join
- not Spanish
- not experts in laparoscopic cholecystectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
Read the 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%.
- Conditions
- Cholelithiasis
- Being tested
- delphi project
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delphi projectOther
delphy study
What is being measured
The primary outcome is the main question the study is designed to answer.
consensus
Likert scale: 1: "totally disagree", 2: "disagree", 3: "neither agree nor disagree", 4: "agree", and 5: "totally agree".
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Jul 2020
- Primary completion15 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Candido Fernando Alcazar-Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Getafe, Complejo Hospitalario Universitario de Badajoz, Hospital Miguel Servet
- Responsible party
- Sponsor-investigator, Candido Fernando Alcazar-Lopez, Hospital General Universitario de Alicante
- Investigators
- Alba Manuel Vázquez, Dr, Principal investigator, Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121181
- Sponsor's protocol ID
- 0
- Status last verified
- Nov 2021
- First submitted
- 22 Jul 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Consensus on the Definition of Difficult Cholecystectomy Among Spanish Experts. A Delphi Project. Qualitative Study
- ClinicalTrials.gov ID
- NCT05121181
- Acronym / sponsor ID
- 0
- Conditions
- Cholelithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Candido Fernando Alcazar-LopezUniversity, hospital or other
- Collaborators
- Hospital Universitario Getafe, Complejo Hospitalario Universitario de Badajoz, Hospital Miguel Servet
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spanish experts in laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- Spanish surgeons
- experts in laparoscopic cholecystectomy, with more than 10 years of experience
Key exclusion criteria (2 listed)
- not Spanish
- not experts in laparoscopic cholecystectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delphi projectdelphy study | Other | – |
Primary outcome
consensus
Time frame: 1 month
Likert scale: 1: "totally disagree", 2: "disagree", 3: "neither agree nor disagree", 4: "agree", and 5: "totally agree".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Related trials for Cholelithiasis
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alba Manuel Vázquez, Dr principal investigator
Hospital Universitario de Getafe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by Candido Fernando Alcazar-Lopez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consensus (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.