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Completed

NCT Number: NCT04511910

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

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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Key information

Conditions

Cholecystitis, Acute Biliary Tract Diseases Cholecystitis Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario German Trias I Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early Laparoscopic Cholecystectomy

Procedure

Primary outcomes

  1. Increased post-operative complications

    Time frame: For at least 30 postoperative days

    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.

  2. Number of Participants with Postoperative hemorrhagia

    Time frame: For at least 30 postoperative days

    Postoperative hemorrhagia

  3. Number of Participants with Biliary fistula

    Time frame: For at least 30 postoperative days

    Biliary fistula

  4. Number of Participants with Jaundice

    Time frame: For at least 30 postoperative days

    Jaundice

  5. Number of Participants with Cardiac insufficiency

    Time frame: For at least 30 postoperative days

    Cardiac insufficiency

  6. Number of Participants with Heart infarction

    Time frame: For at least 30 postoperative days

    Heart infarction

  7. Number of Participants with Respiratory insufficiency

    Time frame: For at least 30 postoperative days

    Respiratory insufficiency

  8. Number of Participants with Pulmonary thromboembolism

    Time frame: For at least 30 postoperative days

    Pulmonary thromboembolism

  9. Number of Participants with Kidney failure or dialysis

    Time frame: For at least 30 postoperative days

    Kidney failure or dialysis

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Collaborators

  • Marcello Di Martino

Registry information

Acronym: CholeRiskScore

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2020
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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