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Acute CholecystitisSPRIMACCNCT04995380

Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis (SPRIMACC)

An observational study of Acute Cholecystitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The SPRIMACC study is a prospective multicenter observational study with the primary endpoint to prospectively validate the Chole-Risk score in predicting a complicated postoperative course (post-operative major complications (Clavien-Dindo>=3a), length of stay (LOS) > 10 days or need of readmission within 30 days… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Cholecystitis
What is being tested?
Early Cholecystectomy
Type of treatment
Surgery or procedure
How many people
1,261 participants
Where
2 sitesin 2 countries
Study dates
1 Sep 2021to 1 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients presenting with ACC as defined according to the Tokyo Guidelines 2018 to one of the participating hospitals will be assessed for eligibility on presentation.

Who may be able to join

  • have a diagnosis of Acute Calculous Cholecystitis (ACC) as defined by Tokyo Guidelines 2018 criteria
  • be candidate to Early Cholecystectomy (EC) during the index admission*
  • be ≥ 18 years old
  • be stratified for the risk of Common Bile Duct Stones (CBDS) according to the Israelian Score, and, in case of confirmation of CBDS receive pre-operative Endoscopic Retrograde Cholangiopancreatography (ERCP).
  • provide signed and dated informed consent form
  • willing to comply with all study procedures and be available for the duration of the study.
  • All the patients treated with initial open cholecystectomy, those who undergo Early Laparoscopic Cholecystectomy (ELC), those with conversion from laparoscopic to open cholecystectomy or those who undergo bail out procedures (e.g. subtotal cholecystectomy) will be included.

Who cannot join

  • pregnancy or lactation
  • acute cholecystitis not related to a gallstone etiology
  • onset of symptoms >10 days before cholecystectomy**
  • concomitant cholangitis or pancreatitis
  • intraoperative treatment of common bile duct stones
  • anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
  • Patients with ACC associated with common bile duct stones who underwent pre-operative ERCP could be included if they receive EC within 10 days from onset of symptoms

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Italy1 site

  • Chirurgia 1, Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

Other trials in Italy

Spain1 site

  • Department of General and Digestive Surgery Hospital Universitario La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) Universidad Autónoma de Madrid (UAM),

    Madrid

Other trials in Spain

About this study

Official title: Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study (SPRIMACC)

The SPRIMACC study is a prospective multicenter observational study with the primary endpoint to prospectively validate the Chole-Risk score in predicting a complicated postoperative course (post-operative major complications (Clavien-Dindo>=3a), length of stay (LOS) > 10 days or need of readmission within 30 days from the discharge) in patients undergoing Early Cholecystectomy (EC) for Acute Calculous Cholecystitis (ACC). The secondary endpoints of the study are to prospectively validate and compare other wellknown risk prediction models (the POSSUM/P-POSSUM score, the Modified Frailty Index (mFI), the Charlson Comorbidity Index (CCI), the American Society of Anesthesiologists (ASA) score and the APACHE II score) in predicting a complicated post-operative course in patients undergoing EC.

Being tested
Early Cholecystectomy
Medical subject headings
Cholecystitis, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early CholecystectomyProcedure or surgery

    Cholecystectomy performed within 10 days from onset of symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complicated post-operative course

    The study outcome is a composite outcome including:

    1. 30-day post-operative major morbidity, intended as Clavien-Dindo >= 3a complication
    2. length of stay (LOS) > 10 days
    3. readmission within 30 days from the discharge after Early Cholecystectomy for Acute Calculous Cholecystis. It is a binary outcome (0/1): in the event of a, b or c occurring, the patient's course is defined as complicated (1). If neither a, b, nor c occur, the course is defined as uncomplicated (0).

    Measured: 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995380
Sponsor's protocol ID
20210057631
Acronym
SPRIMACC
Status last verified
Dec 2022
First submitted
27 Jul 2021
Last updated
12 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Di Martino M, Mora-Guzman I, Jodra VV, Dehesa AS, Garcia DM, Ruiz RC, Nisa FG, Moreno FM, Batanero SA, Sampedro JEQ, Cumplido PL, Bravo AA, Rubio-Perez I, Asensio-Gomez L, Aranda FP, Farrarons SS, Moreno CR, Moreno CMM, Lasarte AS, Calvo MP, Aparicio-Sanchez D, Del Pozo EP, Pellino G, Martin-Perez E. How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score. J Gastrointest Surg. 2021 Nov;25(11):2814-2822. doi: 10.1007/s11605-021-04956-9. Epub 2021 Feb 24.

    PubMed 33629230

  • Fugazzola P, Cobianchi L, Di Martino M, Tomasoni M, Dal Mas F, Abu-Zidan FM, Agnoletti V, Ceresoli M, Coccolini F, Di Saverio S, Dominioni T, Fare CN, Frassini S, Gambini G, Leppaniemi A, Maestri M, Martin-Perez E, Moore EE, Musella V, Peitzman AB, de la Hoz Rodriguez A, Sargenti B, Sartelli M, Vigano J, Anderloni A, Biffl W, Catena F, Ansaloni L; S.P.Ri.M.A.C.C. Collaborative Group. Prediction of morbidity and mortality after early cholecystectomy for acute calculous cholecystitis: results of the S.P.Ri.M.A.C.C. study. World J Emerg Surg. 2023 Mar 18;18(1):20. doi: 10.1186/s13017-023-00488-6.

    PubMed 36934276

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Cholecystitis, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complicated post-operative course (time frame: 30 days after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04995380, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.

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