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| Name | Class |
|---|---|
| Marcello Di Martino | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early surgery Group 1 | The surgery is performed within the first 3 days |
| |
| Early surgery Group 2 | Surgery is performed between the fourth and seventh day |
| |
| Early surgery Group 3 | Surgery is performed more than 7 days from the onset of symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Laparoscopic Cholecystectomy | Procedure |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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CLP surgery patients between January 2013 and December 2018. The diagnosis of acute cholecystitis will be established according to the Tokio Guidelines:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario German Trias I Pujol | Badalona | Barcelona | Spain | |||
| Hospital Universitario Marqués de Valdecilla |
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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 |
| Santander |
| Cantabria |
| Spain |
| Hospital Universitario Príncipe de Asturias | Alcalá de Henares | Madrid | Spain |
| Hospital de Cabueñes | Gijón | Principality of Asturias | Spain |
| Hospital Universitario Cruces | Bilbao | Vizcaya | Spain |
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| Complejo Asistencial Universitario Salamanca | Salamanca | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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