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

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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

100

Start Date

January 1, 2013

Completion Date

September 30, 2020

Primary Completion Date

September 30, 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

August 2020