Condition category
Digestive System
Date applied
29/01/2020
Date assigned
31/01/2020
Last edited
31/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Keyhole surgery for gall bladder removal (laparoscopic cholecystectomy) is currently and worldwide considered the gold standard for the treatment of gallbladder stones. Since its introduction, in the early 1990s, this procedure has gained a remarkable consensus until becoming a routine surgical procedure. However, this procedure comes with an increased incidence of bile duct injuries (BDI), compared to open cholecystectomy (OC): 0.3% and 0.8% vs 0.2%. Strasberg introduced in 1995 the "Critical View of Safety" (CVS) to promote the recognition of the gallbladder elements in order to reduce the risk of BDI and to avoid mistakes due to anatomical alterations and altered visual perception.
The SYoN (Strasberg Yes or No) study is a multicentre Italian observational prospective cohort study, performed by collecting and analysing clinical data of patients managed in 30 Italian surgical departments, affiliated with the Italian Digestive Pathology Society (SIPAD), over a study period of 2 years. The study was conducted prospectively with the insertion of patients on a national database whose data, however, were retrospectively collected after patient discharge not to influence patient management. This prospective study aimed to assess the impact of the correct application of CVS principles during LC on the incidence of postoperative complications, such as BDI and bleeding.

Who can participate?
Adult patients treated with Laparoscopic Cholecystectomy at one of the study sites.

What does the study involve?
Patients will be treated as usual. The data will be collected after patient discharge not to influence patient management. Patients receive the most suitable surgical treatment based on their clinical conditions, the preoperative study, and the intraoperative findings.

What are the possible benefits and risks of participating?
The study doesn’t influence the management of patients causing any risk for participating but aiming to analyse the effective application of CVS in the current surgical practice. This study could be potentially useful to encourage the safest management in case of CVS not applicable such as open conversion and subtotal cholecystectomy.

Where is the study run from?
Department of Biomedical Sciences and Human Oncology - Unit of General Surgery "V. Bonomo" University Medical School of Bari (Italy)

When is the study starting and how long is it expected to run for?
March 2017 to March 2019

Who is funding the study?
Universita degli Studi di Bari Aldo Moro (Italy)

Who is the main contact?
Prof. Mario Testini (scientific)
mario.testini@uniba.it
Dr Lucia Sgaramella (public)
ilaria.sgaram@gmail.com

Trial website

https://www.sipad.it/area_04_pubblicazioni/protocollo_testini.aspx

Contact information

Type

Scientific

Primary contact

Prof Mario Testini

ORCID ID

https://orcid.org/0000-0002-9297-4894

Contact details

Polyclinic Hospital of Bari
Piazza Giulio Cesare
11
Bari
70124
Italy
+39 3355370914
mario.testini@uniba.it

Type

Public

Additional contact

Dr Lucia Sgaramella

ORCID ID

https://orcid.org/0000-0002-6087-4119

Contact details

Via P. Carbonara
22
Bitonto (Bari)
70032
Italy
+39 3468521216
ilaria.sgaram@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Uniba-5674

Study information

Scientific title

The impact of the correct application of critical view of safety (CVS) principles during laparoscopic cholecystectomy on the incidence of postoperative complications

Acronym

SYoN

Study hypothesis

The CVS is the safest technique for recognizing the elements of the Calot triangle and in preventing intra-operative complications (iatrogenic lesions and perioperative bleeding).

Ethics approval

Approved 17/10/2018, Ethics Committee of the University of Bari (Policlinico di Bari - P.zza G. Cesare n. 11, Bari- 70124, Italy; +39 (0)80 5593399; comitatoetico@policlinico.ba.it), ref: 5674

Study design

Multicentre observational prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute cholecystitis and cholelithiasis

Intervention

All members of SIPAD society (Italian Digestive Pathology Society) will be invited by email to participate in the study through an online questionnaire. The questionnaire (23 questions divided into six forms) examines the preoperative workup, the laparoscopic training of the first surgeon, the intraoperative management of the patient, and the post-operative phase concerning any BDI and peri-operative bleeding.

Patients submitted to emergency LC for acute cholecystitis, elective LC for chronic pathologies, and patients treated with LC during other major laparoscopic surgeries are eligible for inclusion if a proper preoperative examination is conducted by the operating surgeon.

In case of declared CVS, the surgeon is asked to judge personally at the end of the procedure if the isolation of the elements is performed according to all the points described by Strasberg, and subsequently to attach an iconographic item (Video or "Doublet Photography") in case of dissection of the Calot triangle with CVS.

During compilation, the iconographic documentation (video or photo) is sent to a dedicated encrypted email address indicating the date of the surgery, the patient's initials, the date of birth and the recruiting centre.

Data collection, compiled by the recruiting centre, is centrally recorded into an electronic database of the data manager (SIPAD), which also ensured the blinding of the lead operator. Finally, an expert surgeon with high skill in hepatobiliary and laparoscopic surgery will review, as external auditor, all the iconographic documentation to establish the strict adherence of the declared manoeuvre with the three principles of the CVS of Strasberg.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Measured using patient records
1. Rate of Bile Duct Injuries
2. Rate of bleeding

Secondary outcome measures

Measured using patient records:
1. Duration of surgery in minutes
2. Length of a hospital stay
3. Operator-related risk factors
4. Patient-related risk factors

Overall trial start date

01/01/2017

Overall trial end date

01/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients submitted to emergency Laparoscopic Cholecystectomy for acute cholecystitis
2. Patients submitted to elective Laparoscopic Cholecystectomy for cholelitiasis
3. Patients treated with Laparoscopic Cholecystectomy during other major laparoscopic surgeries

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

650

Participant exclusion criteria

1. Patients submitted to open cholecystectomy
2. Patients submitted to laparoscopy converted to open surgery
3. Patients submitted to surgery with evidence of malignant pathologies of the gallbladder

Recruitment start date

01/03/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

Italy

Trial participating centre

University Medical School of Bari
Department of Biomedical Sciences and Human Oncology - Unit of General Surgery V. Bonomo Piazza G. Cesare, 11
Bari
70124
Italy

Trial participating centre

Sant' Andrea Hospital
Department of General Surgery Via Vittorio Veneto, 197
La Spezia
19121
Italy

Trial participating centre

San Donato Hospital
Department of Surgery, Division of General Surgery via Pietro Nenni 20-22
Arezzo
52100
Italy

Trial participating centre

Cles Hospital
Department of Surgery, Division of General Surgery via Degasperi 31
Cles
38023
Italy

Trial participating centre

Sant' Elena Hospital
Department of Surgery, Division of General Surgery Via Guglielmo Marconi, 160
Quartu Sant'Elena
09045
Italy

Trial participating centre

San Martino Hospital & National Cancer Institute
Surgery Unit 1 Largo Rosanna Benzi, 10
Genova
16132
Italy

Trial participating centre

Federico II University of Naples
Department of Clinical Medicine and Surgery Via Sergio Pansini, 5
Naples
80131
Italy

Trial participating centre

Parma University Hospital
Emergency Surgery Department Viale Antonio Gramsci, 14
Parma
43126
Italy

Trial participating centre

Policlinico San Martino IRCCS
Department of Surgery Largo Rosanna Benzi, 10
Genova
16132
Italy

Trial participating centre

San Bonifacio (ULSS9 Scaligera)
Department of Surgery Via Circonvallazione, 1
San Bonifacio
37047
Italy

Trial participating centre

Hospital of Brescia
Department of Surgery Via Bezzecca, 10
Brescia
25128
Italy

Trial participating centre

ASST Nord Milano
Department of Surgery Viale Giacomo Matteotti, 83
Sesto San Giovanni
20099
Italy

Trial participating centre

IRCCS policlinico San Matteo
Department of Surgery Viale Camillo Golgi, 19
Pavia
27100
Italy

Trial participating centre

Department of Surgery, Villa Esther
Via dei Due Principati, 169,
Avellino AV
83100
Italy

Trial participating centre

ASST FBF Sacco
Department of Surgery Via G.B Grassi, 74
Milano
20157
Italy

Trial participating centre

Hospital of Ponderano
Department of Surgery Via dei Ponderanesi, 2
Biella
13875
Italy

Trial participating centre

Hospital "Sant'Elia"
Department of surgery Via Luigi Russo, 6
Caltanissetta
93100
Italy

Trial participating centre

Hospital Vanvitelli
Department Of Surgery Piazza Luigi Miraglia, 2
Naples
80138
Italy

Trial participating centre

Hospital of Prato
Department of Surgery Via Suor Niccolina Infermiera, 20/22
Prato
59100
Italy

Trial participating centre

University Medical School "A. Moro" of Bari
Unit of Laparoscopic Surgery, Department of Emergency and Organ Transplantation Piazza G. Cesare, 11
Bari
70124
Italy

Trial participating centre

University of Palermo, Policlinico P. Giaccone
Department of Surgical, Oncological and Oral Sciences (Di. Chir. On. S.) Via Liborio Giuffré 5
Palermo
90127
Italy

Sponsor information

Organisation

University of Bari Aldo Moro

Sponsor details

Unit of General Surgery "V. Bonomo"
Department of Biomedical Sciences and Human Oncology
University Medical School "Aldo Moro" of Bari
Piazza Giulio Cesare
11
Bari
70124
Italy
+39 3355370914
mario.testini@uniba.it

Sponsor type

Hospital/treatment centre

Website

http://www.uniba.it/english-version

Funders

Funder type

University/education

Funder name

Universita degli Studi di Bari Aldo Moro

Alternative name(s)

University of Bari Aldo Moro

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Italy

Results and Publications

Publication and dissemination plan

Publication in Surgical Endoscopy.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

31/01/2020: Trial’s existence confirmed by Ethics Committee of the University of Bari.