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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04511910
Acronym
CholeRiskScore
Enrollment
1868
Registered
2020-08-13
Start date
2013-01-01
Completion date
2020-09-30
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Acute

Keywords

Acute cholecystitis, Cholecystectomy, Gallbladder

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.

Interventions

Sponsors

Marcello Di Martino
CollaboratorUNKNOWN
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Increased post-operative complicationsFor at least 30 postoperative daysPatients 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 hemorrhagiaFor at least 30 postoperative daysPostoperative hemorrhagia
Number of Participants with Biliary fistulaFor at least 30 postoperative daysBiliary fistula
Number of Participants with JaundiceFor at least 30 postoperative daysJaundice
Number of Participants with Cardiac insufficiencyFor at least 30 postoperative daysCardiac insufficiency
Number of Participants with Heart infarctionFor at least 30 postoperative daysHeart infarction
Number of Participants with Respiratory insufficiencyFor at least 30 postoperative daysRespiratory insufficiency
Number of Participants with Pulmonary thromboembolismFor at least 30 postoperative daysPulmonary thromboembolism
Number of Participants with Kidney failure or dialysisFor at least 30 postoperative daysKidney failure or dialysis

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026