- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511910
How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score (CholeRiskScore)
Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice.
Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Madrid, Spain
- Hospital General Universitario Gregorio Marañon
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Madrid, Spain, 28006
- Hospital Universitario de La Princesa
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Madrid, Spain
- Hospital Universitario La Paz
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Madrid, Spain
- Hospital Universitario Ramón y Cajal
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Salamanca, Spain
- Complejo Asistencial Universitario Salamanca
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Sevilla, Spain
- Hospital Universitario Virgen del Rocio
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Asturias
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Gijón, Asturias, Spain
- Hospital de Cabueñes
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Barcelona
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Badalona, Barcelona, Spain
- Hospital Universitario German Trias i Pujol
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Cantabria
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Santander, Cantabria, Spain
- Hospital Universitario Marques de Valdecilla
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Madrid
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Alcalá De Henares, Madrid, Spain
- Hospital Universitario Príncipe de Asturias
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Vizcaya
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Bilbao, Vizcaya, Spain
- Hospital Universitario Cruces
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
CLP surgery patients between January 2013 and December 2018. The diagnosis of acute cholecystitis will be established according to the Tokio Guidelines:
- Local signs (pain in right hypochondrium / Murphy's sign).
- Systemic (fever / elevated C-reactive protein / leukocytosis)
- Ultrasound findings (gallbladder distension, wall thickening, pericolectic fluid or radiological Murphy's sign, associated with gallstones). In all patients, treatment with antibiotics will be carried out according to each hospital's protocols in terms of type and duration.
Description
Inclusion Criteria:
- Patients aged 18 years or older diagnosed with Acute calculous cholecystitis.
- Consecutive patients undergoing early laparoscopic cholecystectomy between January 2013 and December 2018 during admission for the acute episode.
- Minimum 30-day post-operative follow-up.
- ASA ≤ 3.
Exclusion Criteria:
- Presence of another concomitant pathology of the bile duct (choledocholithiasis, cholangitis, pancreatitis, biliary peritonitis).
- Aetiology other than cholelithiasis (amythiasis, malignancy).
- Patients with severe sepsis, immunosuppression and pregnancy.
- Additional abdominal surgical procedure.
- ASA 4.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Early surgery Group 1
The surgery is performed within the first 3 days
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Early surgery Group 2
Surgery is performed between the fourth and seventh day
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Early surgery Group 3
Surgery is performed more than 7 days from the onset of symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased post-operative complications
Time Frame: For at least 30 postoperative days
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Patients who only developed Clavien-Dindo I-II complications were assigned to group 1 (G1), whereas groups 2 (G2) included patients with post-operative complications ≥ IIIa.
Patients with post-operative LOS greater than 10 days and who required readmissions within 30 days from the discharge were also assigned to G2.
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For at least 30 postoperative days
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Number of Participants with Postoperative hemorrhagia
Time Frame: For at least 30 postoperative days
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Postoperative hemorrhagia
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For at least 30 postoperative days
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Number of Participants with Biliary fistula
Time Frame: For at least 30 postoperative days
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Biliary fistula
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For at least 30 postoperative days
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Number of Participants with Jaundice
Time Frame: For at least 30 postoperative days
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Jaundice
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For at least 30 postoperative days
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Number of Participants with Cardiac insufficiency
Time Frame: For at least 30 postoperative days
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Cardiac insufficiency
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For at least 30 postoperative days
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Number of Participants with Heart infarction
Time Frame: For at least 30 postoperative days
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Heart infarction
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For at least 30 postoperative days
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Number of Participants with Respiratory insufficiency
Time Frame: For at least 30 postoperative days
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Respiratory insufficiency
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For at least 30 postoperative days
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Number of Participants with Pulmonary thromboembolism
Time Frame: For at least 30 postoperative days
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Pulmonary thromboembolism
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For at least 30 postoperative days
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Number of Participants with Kidney failure or dialysis
Time Frame: For at least 30 postoperative days
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Kidney failure or dialysis
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For at least 30 postoperative days
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CholeRisk Score
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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