Brief Title
How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score
Official Title
How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score
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.
Study Type
Observational
Primary Outcome
Increased post-operative complications
Condition
Cholecystitis, Acute
Intervention
Early Laparoscopic Cholecystectomy
Study Arms / Comparison Groups
Early surgery Group 1
Description: The surgery is performed within the first 3 days
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1868
Start Date
January 1, 2013
Completion Date
September 30, 2020
Primary Completion Date
July 31, 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04511910
Organization ID
CholeRisk Score
Responsible Party
Sponsor
Study Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborators
Marcello Di Martino
Study Sponsor
, ,
Verification Date
December 2020