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

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 Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

1868

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Salamanca, Spain
        • Complejo Asistencial Universitario Salamanca
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
    • Asturias
      • Gijón, Asturias, Spain
        • Hospital de Cabueñes
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Universitario German Trias i Pujol
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Alcalá De Henares, Madrid, Spain
        • Hospital Universitario Príncipe de Asturias
    • Vizcaya
      • Bilbao, Vizcaya, Spain
        • Hospital Universitario Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CLP surgery patients between January 2013 and December 2018. The diagnosis of acute cholecystitis will be established according to the Tokio Guidelines:

  • Local signs (pain in right hypochondrium / Murphy's sign).
  • Systemic (fever / elevated C-reactive protein / leukocytosis)
  • Ultrasound findings (gallbladder distension, wall thickening, pericolectic fluid or radiological Murphy's sign, associated with gallstones). In all patients, treatment with antibiotics will be carried out according to each hospital's protocols in terms of type and duration.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
For at least 30 postoperative days
Number of Participants with Postoperative hemorrhagia
Time Frame: For at least 30 postoperative days
Postoperative hemorrhagia
For at least 30 postoperative days
Number of Participants with Biliary fistula
Time Frame: For at least 30 postoperative days
Biliary fistula
For at least 30 postoperative days
Number of Participants with Jaundice
Time Frame: For at least 30 postoperative days
Jaundice
For at least 30 postoperative days
Number of Participants with Cardiac insufficiency
Time Frame: For at least 30 postoperative days
Cardiac insufficiency
For at least 30 postoperative days
Number of Participants with Heart infarction
Time Frame: For at least 30 postoperative days
Heart infarction
For at least 30 postoperative days
Number of Participants with Respiratory insufficiency
Time Frame: For at least 30 postoperative days
Respiratory insufficiency
For at least 30 postoperative days
Number of Participants with Pulmonary thromboembolism
Time Frame: For at least 30 postoperative days
Pulmonary thromboembolism
For at least 30 postoperative days
Number of Participants with Kidney failure or dialysis
Time Frame: For at least 30 postoperative days
Kidney failure or dialysis
For at least 30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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