How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score

Study Overview
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Brief Summary
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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.

Official Title
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How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score

Conditions
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Cholecystitis, Acute

Intervention / Treatment
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* Procedure: Early Laparoscopic Cholecystectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early surgery Group 1<br>The surgery is performed within the first 3 days | Procedure: Early Laparoscopic Cholecystectomy<br> <br> |
| Early surgery Group 2<br>Surgery is performed between the fourth and seventh day | Procedure: Early Laparoscopic Cholecystectomy<br> <br> |
| Early surgery Group 3<br>Surgery is performed more than 7 days from the onset of symptoms | Procedure: Early Laparoscopic Cholecystectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased post-operative complications | 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. | For at least 30 postoperative days | 
| Number of Participants with Postoperative hemorrhagia | Postoperative hemorrhagia | For at least 30 postoperative days | 
| Number of Participants with Biliary fistula | Biliary fistula | For at least 30 postoperative days | 
| Number of Participants with Jaundice | Jaundice | For at least 30 postoperative days | 
| Number of Participants with Cardiac insufficiency | Cardiac insufficiency | For at least 30 postoperative days | 
| Number of Participants with Heart infarction | Heart infarction | For at least 30 postoperative days | 
| Number of Participants with Respiratory insufficiency | Respiratory insufficiency | For at least 30 postoperative days | 
| Number of Participants with Pulmonary thromboembolism | Pulmonary thromboembolism | For at least 30 postoperative days | 
| Number of Participants with Kidney failure or dialysis | Kidney failure or dialysis | For at least 30 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholecystitis, Cholecystectomy, Gallbladder