How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score
- Conditions
- Cholecystitis, Acute
- Interventions
- Procedure: Early Laparoscopic Cholecystectomy
- Registration Number
- NCT04511910
- Lead Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1868
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Early surgery Group 2 Early Laparoscopic Cholecystectomy Surgery is performed between the fourth and seventh day Early surgery Group 3 Early Laparoscopic Cholecystectomy Surgery is performed more than 7 days from the onset of symptoms Early surgery Group 1 Early Laparoscopic Cholecystectomy The surgery is performed within the first 3 days
- Primary Outcome Measures
Name Time Method Number of Participants with Biliary fistula For at least 30 postoperative days Biliary fistula
Number of Participants with Kidney failure or dialysis For at least 30 postoperative days Kidney failure or dialysis
Increased post-operative complications For at least 30 postoperative days 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.
Number of Participants with Postoperative hemorrhagia For at least 30 postoperative days Postoperative hemorrhagia
Number of Participants with Jaundice For at least 30 postoperative days Jaundice
Number of Participants with Cardiac insufficiency For at least 30 postoperative days Cardiac insufficiency
Number of Participants with Heart infarction For at least 30 postoperative days Heart infarction
Number of Participants with Respiratory insufficiency For at least 30 postoperative days Respiratory insufficiency
Number of Participants with Pulmonary thromboembolism For at least 30 postoperative days Pulmonary thromboembolism
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Hospital de Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital Universitario German Trias I Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Príncipe de Asturias
🇪🇸Alcalá De Henares, Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Cruces
🇪🇸Bilbao, Vizcaya, Spain
Complejo Asistencial Universitario Salamanca
🇪🇸Salamanca, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain