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

Cholecystitis, Acute Clinical Trial

— CholeRiskScore  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511910
• Other study ID #: CholeRisk Score
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1868
• Est. completion date: September 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Postoperative Complications

Intervention

Procedure:
• Early Laparoscopic Cholecystectomy

Locations

Country	Name	City	State
Spain	Hospital Universitario Príncipe de Asturias	Alcalá De Henares	Madrid
Spain	Hospital Universitario German Trias I Pujol	Badalona	Barcelona
Spain	Hospital Universitario Cruces	Bilbao	Vizcaya
Spain	Hospital de Cabueñes	Gijón	Asturias
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Complejo Asistencial Universitario Salamanca	Salamanca
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Marcello Di Martino

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants with Postoperative hemorrhagia	Postoperative hemorrhagia	For at least 30 postoperative days
Primary	Number of Participants with Biliary fistula	Biliary fistula	For at least 30 postoperative days
Primary	Number of Participants with Jaundice	Jaundice	For at least 30 postoperative days
Primary	Number of Participants with Cardiac insufficiency	Cardiac insufficiency	For at least 30 postoperative days
Primary	Number of Participants with Heart infarction	Heart infarction	For at least 30 postoperative days
Primary	Number of Participants with Respiratory insufficiency	Respiratory insufficiency	For at least 30 postoperative days
Primary	Number of Participants with Pulmonary thromboembolism	Pulmonary thromboembolism	For at least 30 postoperative days
Primary	Number of Participants with Kidney failure or dialysis	Kidney failure or dialysis	For at least 30 postoperative days