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

NCT04511910 | Completed

• 1 other identifier: CholeRisk Score
• Study Type: observational
• Target: 1,868
• Locations: 1 country
• Sites: 11

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.

Conditions

Cholecystitis, Acute

Keywords

Acute cholecystitis; Cholecystectomy; Gallbladder

Outcome Measures

Primary Outcomes (9)

• Increased post-operative complications

  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

  Postoperative hemorrhagia

  For at least 30 postoperative days

• Number of Participants with Biliary fistula

  Biliary fistula

  For at least 30 postoperative days

• Number of Participants with Jaundice

  Jaundice

  For at least 30 postoperative days

• Number of Participants with Cardiac insufficiency

  Cardiac insufficiency

  For at least 30 postoperative days

• Number of Participants with Heart infarction

  Heart infarction

  For at least 30 postoperative days

• Number of Participants with Respiratory insufficiency

  Respiratory insufficiency

  For at least 30 postoperative days

• Number of Participants with Pulmonary thromboembolism

  Pulmonary thromboembolism

  For at least 30 postoperative days

• Number of Participants with Kidney failure or dialysis

  Kidney failure or dialysis

  For at least 30 postoperative days

Study Arms (3)

Early surgery Group 1

The surgery is performed within the first 3 days

Procedure: Early Laparoscopic Cholecystectomy

Early surgery Group 2

Surgery is performed between the fourth and seventh day

Procedure: Early Laparoscopic Cholecystectomy

Early surgery Group 3

Surgery is performed more than 7 days from the onset of symptoms

Procedure: Early Laparoscopic Cholecystectomy

Interventions

Early Laparoscopic Cholecystectomy PROCEDURE

Early surgery Group 1; Early surgery Group 2; Early surgery Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación de Investigación Biomédica - Hospital Universitario de La Princesa: lead
• Marcello Di Martino: collaborator

Study Sites (11)

Hospital Universitario German Trias I Pujol

Badalona, Barcelona, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital de Cabueñes

Gijón, Principality of Asturias, Spain

Location

Hospital Universitario Cruces

Bilbao, Vizcaya, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Complejo Asistencial Universitario Salamanca

Salamanca, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: January 1, 2013
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: March 29, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11)